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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.01  Cytotoxic drugs
Pegaspargase 3750iu vial
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Red
 
Link  NICE TA408: Pegaspargase for treating acute lymphoblastic leukaemia
 
08.01  Side-effects of cytotoxic drugs
08.01  Drugs for cytotoxic-induced side-effects
Calcium Folinate
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Red
  • Approved for methotrexate-induced mucositis and myelosuppression. The following formulations are approved:
    • 15mg tablets.
    • 3mg, 15mg, 30mg, and 300mg injections
    • A calcium folinate 1mg per ml mouthwash can be prepared if needed.unlicensedunlicensed

 
 
Dexrazoxane  (Savene®)
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Red
  • For use in line with NECN extravasation.
 
 
Mesna
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Red
  • Approved formulations include 1gram in 10ml injection and 400mg tablets.
 
 
Glucarpidase
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Unlicensed Drug Unlicensed
Red
  • Approved for the urgent treatment of methotrexate-induced renal
    dysfunction.
 
Link  NHS England: Glucarpidase for the urgent treatment of methotrexateinduced renal dysfunction
 
08.01.01  Alkylating drugs
Cytotoxic Drug Bendamustine
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Red
  • Approved for the first line treatment of CLL (Binet stage B or C) in, patients for whom fludarabine combination chemotherapy is not appropriate in line with NICE. 
  • NECDAG approved for use in combination with rituximab for patients with CLL not fit for FCR chemotherapy and not fit for alemtuzumab. 
  • Approved for Low Grade Non-Hodgkins Lymphoma in line with NICE - not recommended for (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen NICE.
 
Link  MHRA Drug Safety Update (July 2017): Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation
Link  MHRA Drug Safety Update (March 2021): Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML)
Link  NICE TA216: Bendamustine for CLL
 
Cytotoxic Drug Busulfan
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Formulary
Red
  • Approved formulations include:
    • 2mg tablets;
    • 25mg capsules (unlicensedunlicensed);
    • 60mg in 10ml injection.

 
 
Cytotoxic Drug Carmustine
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Red
  • Approved formualtions include 100mg injection and 7.7mg implants.
  • Approved for newly diagnosed glioblastoma multiforme (GBM) in line with NICE.
 
Link  NICE TA121: Glioma (newly diagnosed and high grade) - carmustine implants and temozolomide
 
Cytotoxic Drug Chlorambucil
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Formulary
Red
 
 
Chlormethine hydrochloride (Ledaga®)
(gel)
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Formulary
Red

  • 160micrograms/g gel 

  • Approved for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma in line with NICE

 
Link  NICE TA720: Chlormethine gel for treating mycosis fungoides-type cutaneous T-cell lymphoma
 
Cytotoxic Drug Cyclophosphamide
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Formulary
Red
 
 
Estramustine Phosphate
(UNDER REVIEW)
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Formulary
Red
 
 
Cytotoxic Drug Ifosfamide
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Formulary
Red
 
 
Cytotoxic Drug Lomustine
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Red
  • Note: 10mg capsules are unlicensedunlicensed.
 
 
Cytotoxic Drug Melphalan
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Red
 
Link  NICE TA822: Melphalan for haematological diseases before allogeneic haematopoietic stem cell transplant (terminated appraisal)
 
Thiotepa
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Red
 
 
Treosulfan
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Red

  • Approved in combination with fludarabine for malignant disease before allogeneic stem cell transplant in line with NICE and NHS England Commissioning Policy

 
Link  NICE TA640: Treosulfan with fludarabine for malignant disease before allogeneic stem cell transplant
 
08.01.02  Anthracyclines and other cytotoxic antibiotics to top
Cytotoxic Drug Bleomycin
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Red
  • Also approved for use in intralesional sclerotherapy in the treatment of low-flow vascular lesions. unlicensedunlicensed indication
 
 
Cytotoxic Drug Dactinomycin
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Red
 
 
Cytotoxic Drug Daunorubicin
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Red
  • The following formualtions are approved:
    • 20mg injection;
    • 10mg, 15mg, 35mg;
    • 40mg prefilled syringes.

 
 
Cytotoxic Drug Doxorubicin
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Formulary
Red
  • Doxorubicin 50mg injection - includes use with DC Beads for use in transcatheter arterial chemoembolisation (TACE) therapy in patients with hepatocellular cancer. 
  • Doxorubicin 20mg & 50mg pegylated liposomal injection - approved for second-line (or subsequent) treatment in advanced ovarian cancer in line with NICE. 
  • Approved for the treatment of recurrent ovarian cancer in line with NICE.
 
Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Link  MHRA Drug Safety Update (July 2020): Liposomal and lipid- complex formulations: name change to reduce medication errors
 
Cytotoxic Drug Epirubicin
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Red
  • Note: epirubicin 100mg injection is unlicensedunlicensed.
 
 
Cytotoxic Drug Idarubicin
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Formulary
Red
  • Approved formulations include:
    • 5mg and 10mg capsules;
    • 10mg injection.

 
 
Cytotoxic Drug Mitomycin
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Red
  • Also approved for treatment in combination with 5-Fluorouracil for bladder cancer concurrent with radiotherapy.
  •  Mitomycin 0.04% preservative free eye drops  are also approved for useGreen Traffic Light - this is unlicensedunlicensed.
 
 
Cytotoxic Drug Mitoxantrone
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Formulary
Red
 
 
Cytotoxic Drug Pixantrone
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Red
  • Approved as a possible treatment for adults with multiply relapsed or refractory aggressive non-Hodgkin's B cell lymphoma if they have previously been treated with rituximab and they are having third- or fourth-line treatment in line with NICE. 
 
Link  NICE TA306: Pixantrone monotherapy
 
08.01.03  Antimetabolites
Cytotoxic Drug Azacitidine
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Formulary
Red
  • Approved for myelodysplastic syndromes, CLL and AML - in line with NICE guidance.
 
Link  NICE TA218: Azacitidine for myelodysplastic syndromes
Link  NICE TA399: Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts
Link  NICE TA827: Oral azacitidine for maintenance treatment of acute myeloid leukaemia after induction therapy
 
Cytotoxic Drug Capecitabine
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Formulary
Red
  • Only approved for use in accordance with NICE guidance.
  • Approved in combination with gemcitabine following surgery for pancreatic cancer in line with NHS England Clinical Commissioning Policy
 
Link  NICE TA100: Colon cancer (adjuvant) - capecitabine and oxaliplatin
Link  NICE TA191: Gastric cancer (advanced) - capecitabine
Link  NICE TA61: Colorectal cancer - capecitabine and tegafur uracil
Link  NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)
Link  MHRA Drug Safety Update (Jan 2014): Capecitabine: risk of severe skin reactions - discontinue treatment
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
 
Cytotoxic Drug Cladribine
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Red
  • 10mg in 10ml solution for preparing infusions; 2mg in 1ml subcutaneous injection 
  • Approved for Hairy cell leukaemia only.

  • 10mg tablets
  • Approved for treating highly active multiple sclerosis in adults in line with NICE
 
Link  MHRA Drug Safety Update (Dec 2017): Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected
Link  MHRA Drug Safety Update (Mar 2022): Cladribine (Mavenclad): new advice to minimise risk of serious liver injury
Link  NICE TA616: Cladribine for treating relapsing–remitting multiple sclerosis
 
Cytotoxic Drug Clofarabine (Evoltra®)
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Red
High Cost Medicine
Cancer Drugs Fund
 
 
Cytotoxic Drug Cytarabine
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  • A cytarabine 50mg vial - intrathecal injection (cytarabine encapsulated in liposomes) is also approved for use. 
 
 
Cytotoxic Drug Daunorubicin/cytarabine (Vyxeos®)
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Red
High Cost Medicine
NHS England

  • Daunorubicin 44mg/cytarabine 100mg powder for solution for infusion

  • Approved for untreated acute myeloid leukaemia in line with NICE

 
Link  NICE TA 552: Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia
Link  MHRA Drug Safety Update (July 2020): Liposomal and lipid- complex formulations: name change to reduce medication errors
 
Cytotoxic Drug Fludarabine Phosphate
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Red
  • Approved for the second line therapy of B-cell CLL in line with NICE.
  • Note: fludarabine is not approved for monotherapy in the first line treatment of CLL - this is in line with NICE.
 
Link  NICE TA119: Fludarabine monotherapy for the first-line treatment of chronic lymphocytic leukaemia
Link  NICE TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia
 
Cytotoxic Drug Fluorouracil
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Red
  • A fluorouracil 10mg in 0.4ml subconjunctival injection (unlicensedunlicensed) is also approved for use. 
  • FOLFIRINOX is approved for the management of selected patients with inoperable pancreatic cancer in patients with performance status 0-1.
 
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
 
Cytotoxic Drug Gemcitabine
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Red

  • Approved in combination with paclitaxel for metastatic breast cancer in line with NICE. 

  • NECDAG approved for the second line treatment of women with partially platinum – sensitive, platinum resistant or platinum refractory advanced ovarian cancer (To be used when liposomal doxorubicin [Caelyx] is unavailable). 

  • Approved for pancreatic cancer in line with NICE. 

  • Approved for the treatment of recurrent ovarian cancer in line with NICE.

  • Approved in combination with capecitabine following surgery for pancreatic cancer in line with NHS England Clinical Commissioning Policy

 
Link  NICE NG85: Pancreatic cancer in adults: diagnosis and management
Link  NICE TA116: Gemcitabine for the treatment of metastatic breast cancer
Link  NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Link  NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)
 
Cytotoxic Drug Mercaptopurine
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Red
  • A mercaptopurine 20mg in 1ml suspension (unlicensedunlicensed) is also approved for use. 
  • Note: when prescribed for inflammatory bowel disease. Amber Traffic Light
 
 
Cytotoxic Drug Methotrexate
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Formulary
Red
  •  Approved formulations:
    • Methotrexate 2.5mg tablets
    • Methotrexate 10mg in 5ml oral solution. unlicensedunlicensed
    • Methotrexate injections (various strengths) – including prefilled syringes.
    • Methotrexate 5mg in 2ml intrathecal injection.
  • NOTE: when used in chronic inflammatory conditions, e.g. Crohn’s disease, rheumatoid arthritis.Amber Traffic Light
  • NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL Red
 
Link  MHRA Drug Safety Update (Sept 2020): Methotrexate once weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
Link  South Tyneside & Sunderland APC Shared Care Guideline - Methotrexate in Neurology
 
NelarabineBlack Triangle (Atriance®)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
 
 
Cytotoxic Drug Pemetrexed
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Formulary
Red
  • Approved for:
    • Mesothelioma in line with NICE (funding has to be agreed on an individual patient basis if treatment is not in line with NICE).
    • Combination with cisplatin for the first line treatment of locally advanced or metastatic NSCLC (non-squamous cell histology) in line with NICE.
    • Maintenance treatment of locally advanced or metastatic NSCLC (non-squamous cell histology) in line with NICE.
    • Maintenance treatment of non-squamous non-small lung cancer after pemetrexed and cisplatin in line with NICE and NHS England Commissioning Policy.

  • Note: pemetrexed is not approved for locally advanced or metastatic NSCLC as per NICE. 
 
Link  NICE TA124: Pemetrexed for the treatment of non-small-cell lung cancer
Link  NICE TA135: Pemetrexed for the treatment of malignant pleural mesothelioma
Link  NICE TA181: Pemetrexed for the first-line treatment of non-small-cell lung cancer
Link  NICE TA190: Pemetrexed for the maintenance treatment of non-small-cell lung cancer
Link  NICE TA402: Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin
 
Cytotoxic Drug Raltitrexed (Tomudex®)
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Formulary
Red
 
 
Tegafur with Gimeracil and Oteracil
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Red
 
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
 
Cytotoxic Drug Tegafur with Uracil
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Red
  • Approved for metastatic colorectal cancer in line with NICE.
 
Link  NICE TA61: Guidance on the use of capecitabine and tegafur with uracil for metastatic colorectal cancer
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity
 
Cytotoxic Drug Tioguanine
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Red
  • 50mg in 1ml suspension is also approved.unlicensedunlicensed
 
 
Trifluridine and tipiracil
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Red
  • Approved for previously treated metastatic colorectal cancer in adults in line with NICE and NHS England Commissioning Policy (SSC1662). 
 
Link  NICE TA 405 - Trifluridine–tipiracil for previously treated metastatic colorectal cancer
Link  NICE TA852: Trifluridine–tipiracil for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after 2 or more treatments
 
08.01.04  Vinca alkaloids and etoposide
Cytotoxic Drug Etoposide
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Red
  • The following formulations are approved for use:
    • 50mg capsules & 100mg capsules;
    • 100mg in 5ml injections;
    • 500mg in 25ml injections.

 
 
Cytotoxic Drug Vinblastine Sulphate
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Red
 
 
Cytotoxic Drug Vincristine Sulphate
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Formulary
Red
 
 
Cytotoxic Drug Vindesine Sulphate
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Formulary
Red
 
 
Cytotoxic Drug Vinorelbine
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Red
  • The following formulations are approved for use:
    • 20mg & 30mg capsules;
    • 10mg in 1ml injections;
    • 50mg in 5ml injections.

 
 
08.01.05  Other antineoplastic drugs
Acalabrutinib (Calquence®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 100mg capsules
  • Approved for treating chronic lymphocytic leukaemia in adults in line with NICE
 
Link  NICE TA689: Acalabrutinib for treating chronic lymphocytic leukaemia
 
Cytotoxic Drug Aflibercept (Zaltrap®)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
 
Link  NICE TA307: Aflibercept in combination with irinotecan and fluorouracil-based therapy for treating metastatic colorectal cancer that has progressed following prior oxaliplatin-based chemotherapy
Link  MHRA Drug Safety Update (April 2016): Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
AlectinibBlack Triangle (Alecensa®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • 150mg capsules
  • Approved as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults in line with NICE 
 
Link  NICE TA536: Alectinib for untreated ALK-positive advanced non-small-cell lung cancer
 
Asciminib (Scemblix®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 20mg and 40mg tablets
  • Approved as an option for treating chronic-phase Philadelphia chromosome-positive chronic myeloid leukaemia without a T315I mutation after 2 or more tyrosine kinase inhibitors in adults, in line with NICE
 
Link  NICE TA813: Asciminib for treating chronic myeloid leukaemia after 2 or more tyrosine kinase inhibitors
 
Cytotoxic Drug Atezolizumab
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Red
High Cost Medicine
NHS England
BlueTeq
  • 840mg/14ml & 1200mg/20m concentrate for solution for infusion (IV)
  • 1875mg/15ml solution for injection (S/C)
  • Approved for treating locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults who have had chemotherapy (and targeted treatment if they have an EGFR- or ALK‑positive tumour).  
  • Approved in combination with bevacizumab for treating advanced or unresectable hepatocellular carcinoma (HCC) in adults who have not had previous systemic treatment in line with NICE
  • Approved for the treatment of advanced non-small-cell lung cancer in line with NICE
  • Approved for untreated PD-L1-positive locally advanced or metastatic urothelial cancer in adults when cisplatin-containing chemotherapy is unsuitable in line with NICE
  • Approved for for adjuvant treatment of resected non-small-cell lung cancer in adults in line with NICE
  • Approved with carboplatin and etoposide is recommended as an option for untreated extensive-stage small-cell lung cancer in adults in line with NICE
  • Approved with nab‑paclitaxel for triple-negative, unresectable, PD‑L1‑positive, locally advanced or metastatic breast cancer in adults who have not had chemotherapy for metastatic disease in line with NICE
  • Approved for untreated PD-L1-positive locally advanced or metastatic urothelial cancer in adults when cisplatin-containing chemotherapy is unsuitable in line with NICE
 
Link  NICE TA520: Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy
Link  NICE TA525: Atezolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy
Link  NICE TA584: Atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer
Link  NICE TA638: Atezolizumab with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer
Link  NICE TA639: Atezolizumab with nab-paclitaxel for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer
Link  NICE TA666: Atezolizumab with bevacizumab for treating advanced or unresectable hepatocellular carcinoma
Link  NICE TA705: Atezolizumab monotherapy for untreated advanced non-small-cell lung cancer
Link  NICE TA739: Atezolizumab for untreated PD-L1-positive advanced urothelial cancer when cisplatin is unsuitable
Link  NICE TA823: Atezolizumab for adjuvant treatment of resected non-small-cell lung cancer
Link  MHRA Drug Safety Update (June 2021): Atezolizumab (Tecentriq▼) and other immune-stimulatory anti-cancer drugs: risk of severe cutaneous adverse reactions (SCARs)
 
Axicabtagene ciloleucel
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
NHS England
  • 0.4 – 2 × 108 cells dispersion for infusion
 
Link  NICE TA872: Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies
Link  NICE TA895: Axicabtagene ciloleucel for treating relapsed or refractory diffuse large B-cell lymphoma after first-line chemoimmunotherapy
 
Brexucabtagene autoleucel (Tecartus®)
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Formulary
Red
Cancer Drugs Fund
NHS England
  • 0.4 – 2 × 108 cells dispersion for infusion
 
Link  NICE TA893: Brexucabtagene autoleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people 26 years and over
 
Cytotoxic Drug Carfilzomib (Kyprolis®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for use in previously treated multiple myeloma in line with NICE and NHSE Commissioning Policy
  • Approved in combination with dexamethasone and lenalidomide for previously treated multiple myeloma in line with NICE

 

 
Link  NICE TA657: Carfilzomib for previously treated multiple myeloma (COVID-19)
Link  NICE TA695: Carfilzomib with dexamethasone and lenalidomide for previously treated multiple myeloma
Link  MHRA Drug Safety Update (Aug 2019): Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events
Link  MHRA Drug Safety Update (Dec 2019): Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus
 
CemiplimabBlack Triangle (Libtayo®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for treating metastatic or locally advanced cutaneous squamous cell carcinoma in adults in line with NICE
 
Link  NICE TA802: Cemiplimab for treating advanced cutaneous squamous cell carcinoma
 
Chlormethine Gel
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Red
NHS England

160 micrograms/g gel

Approved for use in accordance with the following NICE TAs or if the indication is funded from the Cancer Drugs Fund:

Overview | Chlormethine gel for treating mycosis fungoides-type cutaneous T-cell lymphoma | Guidance | NICE

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

 
 
Crisantaspase (Erwinase)
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Formulary
Red
 
 
Cytotoxic Drug Crizanlizumab (Adakveo®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved preventing sickle cell crises in people aged 16 or over with sickle cell disease in line with NICE

 

 
Link  NICE TA743: Crizanlizumab for preventing sickle cell crises in sickle cell disease
 
Cytotoxic Drug Dacomitinib (Vizimpro®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer in adults in line with NICE

 

 
Link  NICE TA595: Dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer
 
Cytotoxic Drug Daratumumab (Darzalex®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved in combination with bortezomib, thalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is suitable in line with NICE
  • Approved as an option for treating relapsed and refractory multiple myeloma in adults who have had a proteasome inhibitor and an immunomodulator, and whose disease progressed on the last treatment in line with NICE
  • Approved with lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable in line with NICE and NHSE Specialised Commissioning guidance

 

 
Link  NICE TA763: Daratumumab in combination for untreated multiple myeloma when a stem cell transplant is suitable
Link  NICE TA783: Daratumumab monotherapy for treating relapsed and refractory multiple myeloma
Link  NICE TA897: Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma
Link  NICE TA917: Daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable
Link  MHRA Drug Safety Update (Aug 2019): Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
 
Cytotoxic Drug Dinutuximab beta (Qarziba®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 20mg/4.5mL concentrate for solution for infusion 
  • Approved for the treatment of high-risk neuroblastoma in people aged 12 months and over in line with NICE
 
Link  NICE TA 538: Dinutuximab beta for treating neuroblastoma
 
Dostarlimab  (Jemperli)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
NHS England

Vial: concentrate for infusion 500 mg/10 mL

 
Link  NICE TA 779: Dostarlimab for previously treated advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency
 
 
Cytotoxic Drug DurvalumabBlack Triangle (Imfinzi®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved for locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation in adults in line with NICE
 
Link  NICE TA798: Durvalumab for maintenance treatment of unresectable non-small-cell lung cancer after platinum-based chemoradiation
 
Entrectinib (Rozlytrek®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors in line with NICE
 
Link  NICE TA643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
Link  NICE TA644 Entrectinib for treating NTRK fusion-positive solid tumours
 
Cytotoxic Drug Eribulin (Halaven®)
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Red
High Cost Medicine
NHS England
  • Approved for the treatment of locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens  in accordance with NICE and NHS England Commissioning Policy
 
Link  NICE TA423: Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens
 
Fedratinib
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Red

Capsule: 100 mg

 
Link  NICE TA 756: Fedratinib for treating disease-related splenomegaly or symptoms in myelofibrosis
 
 
FostamatinibBlack Triangle
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Formulary
Red

100mg and 150mg film-coated tablets

Approved for use in accordance with the following NICE TAs or if the indication is funded from the Cancer Drugs Fund:

• NICE TA835: Fostamatinib for treating refractory chronic immune thrombocytopenia

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

 
Link  NICE TA835: Fostamatinib for treating refractory chronic immune thrombocytopenia
 
Cytotoxic Drug Gemtuzumab ozogamicin (Mylotarg®)
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Red
High Cost Medicine
NHS England
BlueTeq
  •  Approved for untreated acute myeloid leukaemia in line with NICE
 
Link  NICE TA545: Gemtuzumab ozogamicin for untreated acute myeloid leukaemia
 
Gilteritinib (Xospata®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for relapsed or refractory FLT3-mutation-positive acute myeloid leukaemia in adults in line with NICE
 
Link  NICE TA642: Gilteritinib for treating relapsed or refractory acute myeloid leukaemia
 
Glofitamab (Columvi®)
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Red
High Cost Medicine
NHS England
  • 2.5mg and 10mg concentrate for solution for infusion
  • Approved for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments in line with NICE and NHSE Specialised Commissioning guidance
 
Link  NICE TA927: Glofitamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments
 
Cytotoxic Drug Idelalisib
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved in combination with rituximab for the treatment of:
    • Untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation; NICE or
    • Chronic lympocytic leukaemia in adults when the disease has been treated but has relapsed within 24 months NICE.

 

 
Link  NICE TA359: Chronic lymphocytic leukaemia - Idelalisib
Link  MHRA Drug Safety Update (May 2016): Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials.
Link  MHRA Drug Safety Update (September 2016): Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection  
 
Imlifidase (Idefirix®)
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Red
High Cost Medicine
NHS England
  • 11mg powder for concentrate for solution for infusion
  • Approved for desensitisation treatment before kidney transplant in people with chronic kidney disease in line with NICE and NHSE Commissioning Policy
 
Link  NICE TA809: Imlifidase for desensitisation treatment before kidney transplant in people with chronic kidney disease
 
Cytotoxic Drug Inotuzumab ozogamicin (Besponsa®)
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Red
High Cost Medicine
NHS England
BlueTeq

  • Approved for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults in line with NICE

 
Link  NICE TA541: Inotuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia
 
IsatuximabBlack Triangle
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Red

20mg/mL concentrate for solution for infusion.

Approved for use in accordance with the following NICE TAs or if the indication is funded from the Cancer Drugs Fund:

• NICE TA658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma

Not approved in accordance with the following NICE TAs:

• NICE TA727: Isatuximab with carfilzomib and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal)

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

 
Link  NICE TA658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma
 
IxazomibBlack Triangle
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Red
  • Capsules: 2.3mg, 3mg, 4mg

 

 
Link  NICE TA870: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma
 
LarotrectinibBlack Triangle
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Formulary
Red
High Cost Medicine
NHS England

20 mg/mL oral solution

 
Link  NICE TA630: Larotrectinib for treating NTRK fusion-positive solid tumours
 
LorlatinibBlack Triangle (Lorviqua®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for previously treated ALK-positive advanced non-small-cell lung cancer in adults in line with NICE
 
Link  NICE TA628: Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer
 
Lutetium (177Lu) oxodotreotideBlack Triangle
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Red
 
 
Cytotoxic Drug Midostaurin (Rydapt®)
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Formulary
Red
NHS England
BlueTeq
  • Approved for the treatment of advanced systemic mastocytosis in line with NICE

 

 
Link  NICE TA523 Midostaurin for untreated acute myeloid leukaemia
Link  NICE TA728: Midostaurin for treating advanced systemic mastocytosis
 
Cytotoxic Drug Mogamulizumab  (Poteligeo®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for previously treated mycosis fungoides and Sézary syndrome in line with NICE

 

 
Link  NICE TA754: Mogamulizumab for previously treated mycosis fungoides and Sézary syndrome
 
Cytotoxic Drug Neratinib (Nerlynx®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for the treatment of early hormone receptor-positive HER2-positive breast cancer after adjuvant trastuzumab in line with NHS England Commissioning Policy and NICE
 
Link  NICE TA612: Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab
 
Niraparib (Zejula®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer in adults in line with NICE
 
Link  MHRA Drug Safety Update (Oct 2020): Niraparib (Zejula▼): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
Link  NICE TA673: Niraparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy
Link  NICE TA784: Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer
 
Cytotoxic Drug Nivolumab  (Opdivo®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • For the treatment of locally advanced or metastatic squamous nonsmall cell lung cancer (NSCLC) after prior chemotherapy in adults.
  • Approved for the treatment of advanced (unresectable or metastatic) melanoma in adults in line with NICE.
  • Approved in combination with ipilimumab for treating advanced melanoma in line with NICE and NHS England Commissioning Policy (SSC1664)
  • Approved for the treatment of advanced renal cell carcinoma in adults in line with NICE and NHS England Commissioning Policy
  • Approved for the treatment of relapsed of refractory classical Hodgkin lymphoma in line with NICE and NHS England Commissioning Policy 
  • Approved for the treatment of  locally advanced or metastatic squamous non-small-cell lung cancer (NSCLC) in adults after chemotherapy in line with NICE
  • Approved for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease in adults
  • Approved for use in patients with previously untreated unresectable advanced or recurrent oesophageal cancer in line with NICE
  • Approved in combination ipilimumab for use in patients with previously treated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency in line with NICE
  • Approved for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy in adults in line with NICE
  • Approved adjuvant treatment of completely resected oesophageal or gastro‑oesophageal junction cancer in adults who have residual disease after previous neoadjuvant chemoradiotherapy in line with NICE
  • Approved in combination with ipilimumab for untreated advanced renal cell carcinoma in line with NICE
  • Approved for adjuvant treatment of invasive urothelial cancer at high risk of recurrence in line with NICE
  • Approved with ipilimumab or untreated unresectable malignant pleural mesothelioma in adults in line with NICE
  • Approved for treating locally advanced or metastatic non-squamous non-small-cell lung cancer (NSCLC) in adults after chemotherapy in line with NICE
  • Approved (with fluoropyrimidine-based and platinum-based combination chemotherapy) for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma in adults whose tumours express PD‑L1 at a level of 1% or more.
  • Approved as an option for the neoadjuvant treatment of resectable (tumours at least 4 cm or node positive) non-small-cell lung cancer (NSCLC) in adults - in line with NICE TA876.
 
Link  MHRA Drug Safety Update (July 2017): Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection
Link  MHRA Drug Safety Update (Oct 2019): Nivolumab (Opdivo): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
Link  NICE TA384: Nivolumab for treating advanced (unresectable or metastatic) melanoma
Link  NICE TA400: Nivolumab in combination with ipilimumab for treating advanced melanoma
Link  NICE TA417: Nivolumab for previously treated advanced renal cell carcinoma
Link  NICE TA462 Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma
Link  NICE TA530: Nivolumab for treating locally advanced unresectable or metastatic urothelial cancer after platinum-containing chemotherapy
Link  NICE TA655: Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy
Link  NICE TA684: Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease
Link  NICE TA707: Nivolumab for previously treated unresectable advanced or recurrent oesophageal cancer
Link  NICE TA713: Nivolumab for advanced non-squamous non-small-cell lung cancer after chemotherapy
Link  NICE TA716: Nivolumab with ipilimumab for previously treated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency
Link  NICE TA724: Nivolumab with ipilimumab and chemotherapy for untreated metastatic non-small- cell lung cancer
Link  NICE TA736: Nivolumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy
Link  NICE TA746: Nivolumab for adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer
Link  NICE TA780: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma
Link  NICE TA817: Nivolumab for adjuvant treatment of invasive urothelial cancer at high risk of recurrence
Link  NICE TA818: Nivolumab with ipilimumab for untreated unresectable malignant pleural mesothelioma
Link  NICE TA865: Nivolumab with fluoropyrimidine- and platinum-based chemotherapy for untreated unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma
Link  NICE TA876: Nivolumab with chemotherapy for neoadjuvant treatment of resectable non-small-cell lung cancer
 
Cytotoxic Drug Olaparib  (Lynparza®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for the maintenance treatment of BRCA 1 or 2 mutated, relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer in people whose relapsed disease has responded to platinum-based chemotherapy in line with NICE.
  • Approved for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer in adults with a BRCA1 or BRCA2 mutation in line with NICE
  • Approved for adjuvant treatment of BRCA mutation-positive HER2-negative high-risk early breast cancer after chemotherapy in adults in line with NICE
  • Approved for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer in adults in line with NICE
  • Approved as maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer after 2 or more courses of platinum-based chemotherapy in adults in line with NICE and NHSE Specialised Commissioning guidance
 
Link  NICE TA886: Olaparib for adjuvant treatment of BRCA mutation-positive HER2-negative high-risk early breast cancer after chemotherapy
Link  NICE TA887: Olaparib for previously treated BRCA mutation-positive hormone-relapsed metastatic prostate cancer
Link  NICE TA908: Olaparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube or peritoneal cancer after 2 or more courses of platinum-based chemotherapy
 
Pablociclib (Ibrance®)
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Red
 
 
Cytotoxic Drug Panobinostat
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved in combination with bortezomib and dexamethasone as an option for the treatment of multiple myeloma in line with NICE.

 

 
Link  NICE TA380: Panobinostat for treating multiple myeloma after at least 2 previous treatments
 
Cytotoxic Drug Pembrolizumab  (Keytruda®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for the treatment of advanced melanoma after disease progression with ipilimumab in accordance with NICE.  
  • Approved for the treatment of advanced melanoma not previously treated with ipilimumab in accordance with NICE. 
  • Approved for treating PD-L1-positive non-small-cell lung cancer 
  • Approved for treating PD-L1-positive metastatic non-small-cell lung cancer 
  • Approved for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD L1 with a combined positive score (CPS) of 1 or more in line with NICE
  • Approved with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations.
  • Approved for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy in adults in line with NICE
  • Approved for untreated metastatic colorectal cancer with high microsatellite instability or mismarhc repair deficiency in line with NICE
  • Approved with platinum- and fluoropyrimidine-based chemotherapy for untreated advanced oesophageal and gastro-oesophageal junction cancer in adults in line with NICE
  • Approved for adjuvant treatment of completely resected stage 3 melanoma in line with NICE
  • Approved in combination with carboplatin and paclitaxel for adults with untreated metastatic squamous non-small-cell lung cancer in line with NICE
  • Approved for treating relapsed or refractory classical Hodgkin lymphoma in people aged 3 and older who have had a stem cell transplant or at least 2 previous therapies in line with NICE
  • Approved with paclitaxel or nab‑paclitaxel for triple-negative, locally recurrent unresectable or metastatic breast cancer in adults who have not had chemotherapy for metastatic disease in line with NICE
  • Approved for adjuvant treatment of renal cell carcinoma in adults in line with NICE
  • Approved for the adjuvant treatment of resected stage 2B and 2C melanoma in people 12 years and over in line with NICE
  • Approved with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer (NSCLC) in adults whose tumours have no epidermal growth factor receptor (EGFR)- or anaplastic lymphoma kinase (ALK)-positive mutations in line with NICE
  • Approved plus chemotherapy with or without bevacizumab for persistent, recurrent or metastatic cervical cancer in adults in line with NICE
  • Approved with lenvatinib for previously treated advanced or recurrent endometrial cancer in line with NICE and NHSE Specialised Commissioning guidance
  • Approved for previously treated endometrial, biliary, colorectal, gastric or small intestine cancer with high microsatellite instability or mismatch repair deficiency in adults in line with NICE and NHSE Specialised Commissioning guidance
 
Link  NICE TA357: Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab
Link  NICE TA366: Pembrolizumab for advanced melanoma not previously treated with ipilimumab
Link  NICE TA428: Pembrolizumab for treating PD-L1-positive non-small-cell lung cancer after chemotherapy
Link  NICE TA531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer
Link  NICE TA661: Pembrolizumab for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma
Link  NICE TA683: Pembrolizumab with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer
Link  NICE TA692: Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy
Link  NICE TA709: Pembrolizumab for untreated metastatic colorectal cancer with high microsatellite instability or mismatch repair deficiency
Link  NICE TA737: Pembrolizumab with platinum- and fluoropyrimidine-based chemotherapy for untreated advanced oesophageal and gastro-oesophageal junction cancer
Link  NICE TA766: Pembrolizumab for adjuvant treatment of completely resected stage 3 melanoma
Link  NICE TA770: Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer
Link  NICE TA772: Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma after stem cell transplant or at least 2 previous therapies
Link  NICE TA801: Pembrolizumab plus chemotherapy for untreated, triple-negative, locally recurrent unresectable or metastatic breast cancer
Link  NICE TA830: Pembrolizumab for adjuvant treatment of renal cell carcinoma
Link  NICE TA837: Pembrolizumab for adjuvant treatment of resected stage 2B or 2C melanoma
Link  NICE TA885: Pembrolizumab plus chemotherapy with or without bevacizumab for persistent, recurrent or metastatic cervical cancer
Link  NICE TA904: Pembrolizumab with lenvatinib for previously treated advanced or recurrent endometrial cancer
Link  NICE TA914: Pembrolizumab for previously treated endometrial, biliary, colorectal, gastric or small intestine cancer with high microsatellite instability or mismatch repair deficiency
Link  MHRA Drug Safety Update (July 2017): Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection
 
Polatuzumab vedotinBlack Triangle (Polivy®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma in adults who cannot have a haematopoietic stem cell transplant in line with NICE
  • Approved with rituximab, cyclophosphamide, doxorubicin and prednisolone (R‑CHP) for untreated diffuse large B-cell lymphoma (DLBCL) in adults - in line with NICE TA874.
 
Link  NICE TA649: Polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma
Link  NICE TA874: Polatuzumab vedotin in combination for untreated diffuse large B-cell lymphoma
 
PomalidomideBlack Triangle
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Formulary
Red

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

 

 

 
Link  NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
 
Ramucirumab (Cyramza®)
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Formulary
Red
High Cost Medicine
 
Link   NICE TA378: Ramucirumab for treating advanced gastric cancer or gastro–oesophageal junction adenocarcinoma previously treated with chemotherapy
Link  NICE TA403: Ramucirumab for previously treated locally advanced or metastatic non-small-cell lung cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Rucaparib
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Formulary
Red
Cancer Drugs Fund

Film coated tablets: 200mg, 250mg, 300mg

 
Link  NICE TA 611: Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
 
Link  MHRA Drug Safety Update (Sep 2022) Rucaparib (Rubraca▼): withdrawal of third-line treatment indication
 
Sacituzumab govitecan (Trodelvy®)
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Red
High Cost Medicine
NHS England
  • 180mg powder for solution for infusion
 
Link  NICE TA819: Sacituzumab govitecan for treating unresectable triple-negative advanced breast cancer after 2 or more therapies
 
SelpercatinibBlack Triangle
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Red
High Cost Medicine
  • 40mg and 80mg capsules
  • Approved for advanced thyroid cancer with RET alterations in people 12 years and older in line with NICE
  • Approved for untreated RET fusion-positive advanced non-small-cell lung cancer in adults in line with NICE
 
Link  NICE TA742: Selpercatinib for treating advanced thyroid cancer with RET alterations
Link  NICE TA760: Selpercatinib for previously treated RET fusion-positive advanced non-small-cell lung cancer
Link  NICE TA911: Selpercatinib for untreated RET fusion-positive advanced non-small-cell lung cancer
 
SelumetinibBlack Triangle (Koselugo®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 10mg and 35mg hard capsules
  • Approved treating symptomatic and inoperable plexiform neurofibromas associated with type 1 neurofibromatosis in children aged 3 and over in line with NICE
 
Link  NICE HST20: Selumetinib for treating symptomatic and inoperable plexiform neurofibromas associated with type 1 neurofibromatosis in children aged 3 and over
 
SotorasibBlack Triangle (Lumykras)
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Formulary
Red

Tablets: 120 mg

 
Link  NICE TA 781: Sotorasib for previously treated KRAS G12C mutation-positive advanced non-small-cell lung cancer
 
 
Cytotoxic Drug Talimogene laherparepvec
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Red
High Cost Medicine
NHS England

  • Approved for the treatment of unresectable metastatic melanoma in line with NICE and NHS England Commissioning Policy (SSC1679).

 
Link  NICE TA410: Talimogene laherparepvec for treating unresectable metastatic melanoma
 
TisagenlecleucelBlack Triangle
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Red
High Cost Medicine
Cancer Drugs Fund
NHS England
  • Indicated for treating 'paediatric and young adult patients up to 25 years of age with B‑cell acute lymphoblastic leukaemia that is refractory, in relapse post‑transplant or in second or later relapse as per NICE

     

  • NICE has recommended tisagenlecleucel for use within the Cancer Drugs Fund for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies. 
Link  NICE TA 554: Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years
Link  NICE TA 567: Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies
 
 
TivozanibBlack Triangle (Fotivda®)
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Formulary
Red
  • Capsules: 890 mg and 1340 mg
 
Link  NICE TA512: Tivozanib for treating advanced renal cell carcinoma
Link  MHRA Drug Safety Updates (July 2020) Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Trastuzumab deruxtecanBlack Triangle (Enhertu)
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Formulary
Red
NHS England

Vial: powder for concentrate for infusion, 100 mg

 
Link  NICE TA704: Trastuzumab deruxtecan for treating HER2-positive unresectable or metastatic breast cancer after 2 or more anti-HER2 therapies
Link  NICE TA862: HER2-positive unresectable or metastatic breast cancer after 1 or more anti-HER2 treatments
 
Cytotoxic Drug Venetoclax (Venclyxto®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved in combination with rituximab for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy in line with NICE
  • Approved in combination with azacitidine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable in line with NICE
  • Approved in combination with low dose cytarabine for untreated acute myeloid leukaemia in adults when intensive chemotherapy is unsuitable in line with NICE.
  • Approved for the treatment of chronic lymphocytic leukaemia in adults:
    • with a 17p deletion or TP53 mutation and when a B‑cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B‑cell receptor pathway inhibitor or
    • without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo‑immunotherapy and a B‑cell receptor pathway inhibitor in line with NICE

 

 
Link  NICE TA561: Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia
Link  NICE TA663 Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia
Link  NICE TA765: Venetoclax with azacitidine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable
Link  NICE TA787: Venetoclax with low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable
Link  NICE TA796: Venetoclax for treating chronic lymphocytic leukaemia
Link  MHRA Drug Safety Update (Dec 2021): Venetoclax (Venclyxto▼): updated recommendations on tumour lysis syndrome (TLS)
 
Picibanil
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Unlicensed Drug Unlicensed
Red
 
 
Streptozocin
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Unlicensed Drug Unlicensed
Red
  • Named patient supply only.
 
 
08.01.05  Amsacrine
Cytotoxic Drug Amsacrine
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Formulary
Red
 
 
08.01.05  CDK inhibitors to top
08.01.05  Arsenic trioxide
Cytotoxic Drug Arsenic Trioxide
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Formulary
Red
  • NECDAG approved relapsed or refractory acute promyelocytic leukaemia (APL).
 
Link  NICE TA526: Arsenic trioxide for treating acute promyelocytic leukaemia
 
08.01.05  Bevacizumab
Bevacizumab (Avastin®)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
 
Link  NICE TA284:Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer
Link  NICE TA285: Ovarian, fallopian tube and primary peritoneal cancer (recurrent advanced, platinum-sensitive or partially platinum-sensitive) - bevacizumab
Link  NICE TA353: Bevacizumab for treating relapsed, platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (terminated appraisal)
Link  MHRA Drug Safety Update (January 2011): Bevacizumab and sunitinib: risk of osteonecrosis of the jaw
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
08.01.05  Bexarotene
Bexarotene (Targretin®)
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Red
 
 
08.01.05  Bortezomib
Cytotoxic Drug Bortezomib
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Red
High Cost Medicine
NHS England
  • Approved for:
    • Relapsed multiple myeloma in line with in line with NICE.
    • Combination with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma in line with NICE. 
    • Induction therapy for multiple myeloma in line with NICE.
    • Treatment of adults with mantle cell lymphoma that has not been treated before, if haemotopoietic stem cell transplantation is not suitable, in line with NICE.
 
Link  NICE TA129: Multiple myeloma - bortezomib
Link  NICE TA228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
Link  NICE TA311: Bortezomib for induction therapy in multiple myeloma before high-dose chemotherapy and autologous stem cell transplantation
Link  NICE TA370: Bortezomib for previously untreated mantle cell lymphoma
 
08.01.05  Brentuximab vedotin to top
Cytotoxic Drug Brentuximab vedotin (Adcetris®)
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Red
High Cost Medicine
  • 50mg powder for concentrate for solution for infusion
  • Approved for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma in line with NICE and NHS England Commissioning Policy.
  • Approved for the treatment of CD30-positive Hodgkin lymphoma in patients:
    • if they have already had autologous stem cell transplant
    • if they have already had at least 2 previous therapies when autologous stem cell transplant or multi-agent chemotherapy are not suitable. CDF
  • Approved for the treatment of CD30-positive cutaneous T-cell lymphoma in line with NICE
  • Approved in combination with cyclophosphamide, doxorubicin and prednisone for untreated systmic anaplastic large cell lymphoma in adults in line with NICE

 

 
Link  NICE TA478 Brentuximab vedotin for treating relapsed or refractory systemic anaplastic large cell lymphoma
Link  NICE TA524 Brentuximab vedotin for treating CD30-positive Hodgkin lymphoma
Link  NICE TA577: Brentuximab vedotin for treating CD30-positive cutaneous T-cell lymphoma
Link  NICE TA641: Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma
 
08.01.05  Cetuximab
Cetuximab
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Red
  • Approved for the first-line treatment of metastatic colorectal cancer in combination with FOLFOX in line with NICE (monotherapy or combination chemotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy -  as per NICE). 
  • NECDAG approved for K-RAS wild type metastatic colorectal cancer; second line use in combination with chemotherapy in patients that have progressed on previous chemotherapy; third line use as a single agent in patients who have failed oxaliplatin- and irinotecan based therapy and who are intolerant to irinotecan. 
  • Approved for locally advanced squamous cell carcinoma of the head and neck in line with NICE. 
  • Approved for previously untreated metastatic colorectal cancer in line with NICE.
  • Approved for the treatment of metastatic and/or recurrent squamous cell carcinoma of the head and neck (oral cavity only) in line with NICE and NHS England Commissioning Policy
  • Note: cetuximab is not approved in combination with platinum-based chemotherapy for recurrent and/or metastatic squamous cell cancer of the head and neck as per NICE.
 
Link  NICE TA145: Cetuximab for the treatment of locally advanced squamous cell cancer of the head and neck
Link  NICE TA242: Cetuximab for the treatment of metastatic colorectal cancer after first-line chemotherapy: monotherapy or combination chemotherapy
Link  NICE TA439 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
Link  NICE TA473 Cetuximab for treating recurrent or metastatic squamous cell cancer of the head and neck (oral cavity)
Link  MHRA Drug Safety Update (Feb 2014): Cetuximab: new safety information available
Link  MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
 
08.01.05  Dacarbazine and Temozolomide
Cytotoxic Drug Dacarbazine
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Red
 
 
Cytotoxic Drug Temozolomide
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Red
  • Approved for the treatment of recurrent malignant glioma in line with NICE.
  • Approved for newly diagnosed glioblastoma multiforme (GBM) in line with NICE.
 
Link  NICE TA121: Glioma (newly diagnosed and high grade)
Link  NICE TA23: Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer)
 
08.01.05  Erlotinib
Erlotinib
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Red
  • Also approved for second line use, as an alternative to docetaxel, in NSCLC in line with NICE.
  • Monotherapy not approved for maintenance after platinum chemotherapy in advanced or metastatic NSCLC NICE.
  • Approved for the treatment of locally advanced or metastatic nonsmall-cell lung cancer that has already been treated with non-targetted chemotherapy because of delayed confirmation of epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation status if; their cancer tests positive for EGFR-TK mutation; it is not know if the cancer is EGFR-TK mutation- positive because of problems with the test, and the cancer is very likely to be EGFR-TK mutation-positive and it responds to the first 2 cycles of treatment with erlotinib - in line with NICE.
 
Link  NICE TA227: Erlotinib monotherapy for maintenance treatment of non-small-cell lung cancer
Link  NICE TA258: Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small-cell lung cancer
Link  NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
Link  Roche Healthcare Professional Letter (January 2016): Tarceva (erlotinib)
Link  MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
 
08.01.05  Hydroxycarbamide
Cytotoxic Drug Hydroxycarbamide
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Red
 
 
08.01.05  Imatinab to top
08.01.05  Ipilimumab
Cytotoxic Drug Ipilimumab (Yervoy®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for previously treated advanced melanoma in line with NICE.
  • Approved for previously untreated advanced melanoma in line with NICE.
  • Approved in combination with nivolumab for untreated renal cell carcinoma in line with NICE.
 
Link  NICE TA268: Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma
Link  NICE TA319: Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma
Link  NICE TA357: Pembrolizumab for treating advanced melanoma after disease progression with ipilimumab
Link  NICE TA400: Nivolumab in combination with ipilimumab for treating advanced melanoma
Link  NICE TA780: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (Jan 2019): Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
 
08.01.05  Mitotane
Mitotane
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Red
 
 
08.01.05  Panitumumab
Panitumumab (Vectibix®)
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Red
High Cost Medicine

  • Approved for previously untreated metastatic colorectal cancer in line with NICE.

 
Link  NICE TA439 Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
Link  MHRA Drug Safety Update (May 2010): Panitumumab (Vectibix): serious hypersensitivity reactions
Link  MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
Link  MHRA Drug Safety Update (September 2012): Panitumumab (Vectibix): risk of necrotising fasciitis
Link  MHRA Drug Safety Update (September 2013): Panitumumab: treatment of metastatic colorectal cancer
 
08.01.05  Pentostatin
Cytotoxic Drug Pentostatin (Nipent®)
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Red
 
 
08.01.05  Platinum compounds to top
Cytotoxic Drug Carboplatin
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Red
 
 
Cytotoxic Drug Cisplatin
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Red
 
 
Cytotoxic Drug Oxaliplatin
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Red
  • Approved for Dukes C colon cancer in combination with 5-fluorouracil
    and folinic acid in line with NICE.
  • Approved for advanced and metastatic colorectal cancer in line with NICE.
 
Link  NICE TA100: Capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes’ C) colon cancer
 
08.01.05  Porfimer sodium and temoporfin
Porfimer Sodium (Photofrin ®)
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Red
 
 
08.01.05  Procarbazine
Cytotoxic Drug Procarbazine
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Red
 
 
08.01.05  Protein kinase inhibitors
Afatinib
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Red
High Cost Medicine
NHS England

  • Approved as a possible treatment for adults with locally advanced or metastatic non-small-cell lung cancer if their cancer tests positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and they have not had an EGFR-TK inhibitor before NICE and additional NHS England criteria.

 
Link  NICE TA310: Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer
 
Axitinib  (Inlyta®)
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Red
High Cost Medicine
NHS England
  • Approved as treatment for adults with advanced renal cell carcinoma when tyrosine kinase inhibitors or cytokines have not worked in line with NICE.

 

 
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Link  NICE TA333: Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment
Link  NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
 
Bosutinib (Bosulif®)
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Red
High Cost Medicine
NHS England
  • Approved as an option for the treatment of chronic, accelerated blast phase Philidephia chromosome positive chronic myeloid leukaemia in adults when they have previously had 1 or more tyrosine kinase inhibitor and imatinib, nilotinib and dasatanib are not appropriate in line with NICE.
 
Link  NICE TA401: Bosutinib for previously treated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Brigatinib (Alunbrig®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib in line with NICE.
  • Approved for treating ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor in line with NICE
 
Link  NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
Link  NICE TA670: Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
 
Cabozantinib (Cometriq®)
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Red
High Cost Medicine
NHS England
  • Approved for use in the treatment of renal cell carcinoma in line with NICE and NHS England Commissioning Policy
  • Approved for the treatment of medullary thyroid cancer in line with NICE and NHS England Commissioning Policy
  • Approved for use in untreated advanced renal cell carcinoma in line with NICE and NHS England Commissioning Policy
 
Link   NICE TA849: Cabozantinib for previously treated advanced hepatocellular carcinoma
Link  NICE TA 542: Cabozantinib for untreated advanced renal cell carcinoma
Link  NICE TA463 Cabozantinib for previously treated advanced renal cell carcinoma
Link  NICE TA516: Cabozantinib for treating medullary thyroid cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Ceritinib
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Red
High Cost Medicine
NHS England
  • Approved for use in previously treated anaplastic lymphoma kinase positive non-small-cell-lung cancer in line with NICE and NHS England Commissioning Policy.
  • Approved for untreated ALK-positive non-small-cell lung cancer in line with NICE and NHS England Commissioning Policy
 
Link  NICE TA395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
Link  NICE TA500: Ceritinib for untreated ALK-positive non-small-cell lung cancer
 
Crizotinib
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Red
High Cost Medicine
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
Link  NICE TA422: Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
Link  NICE TA529: Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
Link  MHRA Drug Safety Update (Nov 2015): Crizotinib (Xalkori▼): risk of cardiac failure
 
Dabrafenib  (Tafinlar®)
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NHS England
BlueTeq
  • Approved for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in line with NICE 
  • Approved for the treatment of BRAF-mutated anaplastic thyroid cancer (ATC) in line with NHSE Specialised Commissioning Policy
  • Approved with trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer in adults in line with NICE

 

 
Link  NICE TA321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma
Link  NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
Link  NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
Link  NICE TA898: Dabrafenib plus trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer
 
Dasatinib (Sprycel®)
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  • Approved for use in accordance with NICE and NHS EnglandCommissioning Policy
 
Link  NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Encorafenib (Braftovi®)
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Red
High Cost Medicine
NHS England

  • Approved in combination with binimetinib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults in line with NICE

  • Approved in combination with cetuximab (Erbitux) for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment

 
Link  NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
Link  NICE TA668: Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer
 
Everolimus (Afinitor®, Votubia®)
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Red
  • 2.5mg, 5mg & 10mg tablets (Votubia®)
    • Approved for the treatment of angiomyolipomas associated with tuberous sclerosis in accordnace with NHS England Commissioning Policy.
    • Approved for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex in accordnace line with NHS England Commissioning Policy.
  • 5mg & 10mg tablets (Afinitor®)
    • Approved, in combination with exemestane, for the treatment of advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women in accordance with NICE.
    • Approved for the treatment of advanced breast cancer after endocrine therapy in line with NICE.
    • Approved for the treatment of advanced renal cell carcinoma after previous treatment in line with NICE.
    • Approved for the treatment of unresectable or metastatic neuroendocrine tumours in people with progressive disease in line with NICE and NHS England Commissioning Policy
 
Link  Clinical Commissioning Policy Statement: Everolimus (Votubia®) for treatment of angiomyolipomas associated with tuberous sclerosis
Link  Clinical Commissioning Policy: Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Link  NICE TA348: Everolimus for preventing organ rejection in liver transplantation
Link  NICE TA421: Everolimus with exemestane for treating advanced breast cancer after endocrine therapy
Link  NICE TA432: Everolimus (Afinitor) for advanced renal cell carcinoma after previous treatment
Link  NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
 
Gefitinib
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Red
  • Approved for first line use in locally advanced or metastatic NSCLC in line with NICE.
 
Link  NICE TA192: Lung cancer (non-small-cell, first line) - gefitinib
Link  NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
Link  MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
 
Ibrutinib (Imbruvica®)
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Red
High Cost Medicine
NHS England
  • Approved for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation in line with NICE and NHS Commissioning Policy.
  • Approved for treating relapsed or refractory mantle cell lymphoma in line with NICE and NHS England Commissioning Policy if:
    • they have had only 1 previous line of therapy
  • Approved for untreated chronic lymphocytic leukaemia in line with NICE
 
Link  NICE TA429: Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
Link  NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
Link  NICE TA795: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
Link  NICE TA891: Ibrutinib with venetoclax for untreated chronic lymphocytic leukaemia
Link  MHRA Drug Safety Update (August 2017): Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
 
Imatinib
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Red
NHS England
  • Approved for the first-line management of people with KIT (CD117)- positive unresectable and/or KIT (CD117)-positive metastatic gastrointestinal stromal tumours (GISTs) in line with NICE. 
  • Approved for the adjuvant treatment of gastrointestinal stromal tumours (GISTs) after surgery when there is a high risk relapse of tumour NICE. 
  • Approved for Philadelphia-chromosome-positive CML in the accelerated phase or with blast crisis in line with NICE.
  • A standard-dose imatinib is recommended as an option for the first-line treatment of adults with chronic phase Philadelphia-chromosomepositive CML in line with NICE.
 
Link  NICE TA209: Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours
Link  NICE TA326: Imatinib for the adjuvant treatment of gastrointestinal stromal tumours
Link  NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  NICE TA70: Guidance on the use of imatinib for chronic myeloid leukaemia
Link  NICE TA86: Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Lapatinib (Tyverb®)
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Red
 
Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
 
Lenvatinib (Kisplyx®)
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Red
High Cost Medicine
NHS England
  • 4mg & 10mg capsules
  • Approved with everolimus for previously treated advanced renal cell carcinoma in line with NICE
  • Approved to the treatment of differentiated thyroid cancer after radioactive iodine in line with NICE
  • Approved for untreated advanced hepatocellular carcinoma in line with NICE
 
Link  NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
Link  NICE TA 551: Lenvatinib for untreated advanced hepatocellular carcinoma
Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Mobocertinib
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Red
High Cost Medicine
NHS England
 
Link  NICE TA855: Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy
 
Nilotinib (Tasigna®)
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Red
NHS England
  • Approved for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive CML in line with NICE and NHS Commissioning Policy
 
Link  NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Nintedanib
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Red
  • Approved for the treatment of locally advanced, metastatic or locally recurrent non-small-cell lung cancer who have previously been treated been with first-line chemotherapy in accordance with NICE.
  • Approved for treating idiopathic pumonary fibrosis in line with NICE
 
Link  NICE TA347: Recurrent non-small-cell lung cancer
Link  NICE TA379: Nintedanib for treating idiopathic pulmonary fibrosis
Link  NICE TA747 Nintedanib for treating progressive fibrosing interstitial lung diseases
Link  NICE TA864: Nintedanib for treating idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Pazopanib (Votrient®)
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Red
  • Approved for advanced renal cell carcinoma in line with NICE
 
Link  NICE TA215: Pazopanib in renal cell cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Pemigatinib (Pemaryze®)
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Red
  • 4.5mg, 9mg and 13.5mg tablets
  • Approved for the treatment of relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement in line with NICE

 

 
Link  NICE TA722: Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement
 
Ponatinib (Iclusig®)
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Red
High Cost Medicine
  • 15mg, 30mg & 45mg film-coated tablets
  • Approved for the treatment of chronic myeloid leukaemia and acute lymphoblastic leukaemia in line with NICE and NHS England Commissioning Policy
 
Link  NICE TA451 Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Link  MHRA Drug Safety Update (October 2018): Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
Link  MHRA Drug Safety Update (April 2017): Ponatinib  (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Regorafenib (Stivarga® )
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Red
High Cost Medicine
BlueTeq
  • 40mg tablets
  • Approved for treating unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib in line with NICE and NHS England Commissioning Policy.
  • Approved for treating advanced hepatocellular carcinoma in adults who have had sorafenib in line with NICE
  • Approved as an option for metastatic colorectal cancer in adults who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti‑VEGF therapy and anti‑EGFR therapy) or when these treatments are unsuitable - in line with NICE.
 
Link  NICE TA 488: Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
Link  NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
Link  NICE TA866: Regorafenib for previously treated metastatic colorectal cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Ruxolitinib
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Red
  • Approved for the treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemiaa myelofibrosis, only in people with intermediate-2 or high-risk disease in line with NICE.
  • Approved for treating polycythaemia vera in line with NICE and NHSE Specialised Commissioning guidance

 

 
Link  NICE TA386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
Link  NICE TA921: Ruxolitinib for treating polycythaemia vera
 
Sorafenib (Nexavar®)
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Red
High Cost Medicine
  • 200mg tablets
  • Approved for treatment of advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment in line with NICE and NHS Commissioning Policy.
  • Approved for the treatment of differentiated thyroid cancer after radioactive iodine in line with NICE.
 
Link  NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
Link  NICE TA474 Sorafenib for treating advanced hepatocellular carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Sunitinib  (Sutent®)
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Red
High Cost Medicine
NHS England
  • Approved for gastrointestinal stromal tumours (GISTs) in line with NICE.
  • Approved for advanced and/or metastatic renal cell carcinoma in line with NICE.
  • Sunitinib not approved for second line use in advanced and/or metastatic renal cell carcinoma NICE.
  • Approved for the treatment of unresectable or metastatic neuroendocrine tumours in people with progressive disease in line with NICE and NHS England Commissioning Policy
 
Link  NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma
Link  NICE TA179: Sunitinib for the treatment of gastrointestinal stromal tumours
Link  NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Link  MHRA Drug Safety Update (January 2011): Bevacizumab and sunitinib: risk of osteonecrosis of the jaw
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Cytotoxic Drug Temsirolimus (Torisel®)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
 
 
Trametinib
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Red
High Cost Medicine
NHS England
  • Approved in combination with dabrafenib for the treatment of unresectable or metastatic melanoma in line with NICE and NHS England Commissioning Policy.
  • Approved for the treatment of BRAF-mutated anaplastic thyroid cancer (ATC) in line with NHSE Specialised Commissioning Policy



 

 
Link  NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
Link  NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
Link  MHRA Drug Safety Update (March 2016) Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis
 
Cytotoxic Drug Tucatinib (Tukysa®)
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Red
High Cost Medicine
NHS England
  • Approved in combination with trastuzumab and capecitabine for HER2‑positive locally advanced or metastatic breast cancer in adults after 2 or more anti‑HER2 treatment therapies in line with NICE
 
Link  NICE TA786: Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies
 
Vemurafenib
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Formulary
Red
  • Approved melanoma (BRAF V600 mutation positive, unresectable metastatic) in line with NICE.
 
Link  NICE TA269: Vemurafenib for treating malignant melanoma
Link  NICE TA414: Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
 
Cytotoxic Drug Zanubrutinib (Brukinsa 80mg capsules®)
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Red
High Cost Medicine
NHS England
  • Capsule, 80mg
 
Link  NICE TA833: Zanubrutinib for treating Waldenstrom’s macroglobulinaemia
 
08.01.05  Taxanes
Cytotoxic Drug Cabazitaxel
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Red
  • Approved for the treatment of hormone relapsed metastatic prostate cancer treated with with docetaxel in line with NICE.
 
Link  MHRA Drug Safety Update (December 2014) Cabazitaxel (Jevtana▼): risk of medication error resulting in overdose
Link  NICE TA391: Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel
 
Cytotoxic Drug Docetaxel
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Formulary
Red
  • Approved for early node-positive breast cancer in line with NICE. 
  • Approved for hormone refractory metastatic prostate cancer in line with NICE.
 
Link  NICE NG101: Early and locally advanced breast cancer: diagnosis and management
Link  NICE TA101: Docetaxel for the treatment of hormone-refractory metastatic prostate cancer
 
Cytotoxic Drug Paclitaxel
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Red
  • The following formulations are approved:
  • 30mg in 5ml, 100mg in 16.7ml, and 150mg in 25ml concentrate for preparing IV infusion.
  • Approved for the treatment of recurrent ovarian cancer in line with NICE.
 
Link  MHRA Drug Safety Update (Jan 2022): Paclitaxel formulations (conventional and nab-paclitaxel): caution required due to potential for medication error
Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Link  NICE TA55: Guidance on the use of paclitaxel in the treatment of ovarian cancer
 
Cytotoxic Drug Paclitaxel - Albumin Bound Formulation (Abraxane®)
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Red
  • Note: Abraxane® 5mg in 1ml powder for suspension for infusion is restricted for use within its current license for metastatic breast cancer patients who cannot tolerate standard taxanes. 
  • Approved in combination with a platinum-based compound or platinum-based therapy alone (cisplatin or carboplatin) for first line therapy in ovarian cancer in line with NICE.
  • Approved in combination with a platinum-based drug (carboplatin or cisplatin) for second-line (or subsequent) therapy in ovarian cancer in line with NICE
  • Approved metastatic breast cancer in line with NICE.
  • Abraxane is not recommended for the adjuvant treatment of women with early node-positive breast cancer NICE.
  • Approved in combination with gemcitabine for untreated metastatic pancreatic cancer in line with NICE and NHS England Commissioning Policy as of 5th December 2017
 
Link  NICE TA476 Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer
Link  MHRA Drug Safety Update (Jan 2022): Paclitaxel formulations (conventional and nab-paclitaxel): caution required due to potential for medication error
 
08.01.05  Topoisomerase I inhibitors to top
Cytotoxic Drug Irinotecan Hydrochloride
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Red
 
 
Cytotoxic Drug Topotecan
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Red
  • Approved for relapsed NSCLC in line with NICE.
  • Approved for recurrent or stage IVB cervical cancer in line with NICE.
  • Approved for second-line (or subsequent) treatment in advanced ovarian cancer in line with NICE.
  • Approved for the treatment of recurrent ovarian cancer in line with NICE.
 
Link  NICE TA183: Topotecan for the treatment of recurrent and stage IVB cervical cancer
Link  NICE TA184: Topotecan for the treatment of relapsed small-cell lung cancer
Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
 
08.01.05  Trabectedin
Cytotoxic Drug Trabectedin
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Red

Approved for the treatment of recurrent ovarian cancer in line with NICE.

 
Link  NICE TA185: Soft tissue sarcoma - trabectedin
Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
 
08.01.05  Trastuzumab
Pertuzumab (Perjeta®)
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High Cost Medicine
NHS England
BlueTeq

  • Approved for the neoadjuvant treatment of HER2-positive breast cancer in line with NICE and NHS Commissioning Policy

  • Approved with trastuzumab and docetaxel for treating HER2-positive breast cancer in line with NICE and NHS Commissioning Policy

  • Approved for adjuvant treatment of HER2-positive early stage breast cancer in line with NICE

 
Link  NICE TA424: Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer
Link  NICE TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
Link  NICE TA569: Pertuzumab for adjuvant treatment of HER2-positive early stage breast cancer
 
Trastuzumab
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  • Approved for metastatic or locally advanced inoperable gastric cancers in line with NICE.
  • Approved for early stage HER2-positive breast cancer in line with NICE.
  • Approved for advanced HER2-positive breast cancer in line with NICE.
  • Note: trastuzumab is not recommended in combination with an aromatase inhibitor for the first-line treatment in postmenopausal women with metastatic hormonereceptor- positive breast cancer that overexpresses HER2 - in line with NICE.
  • Trastuzumab 600mg subcutaneous injection is approved by NHS England for HER2-positive breast cancer in line with NECN guidance.
 
Link  NICE NG101: Early and locally advanced breast cancer: diagnosis and management
Link  NICE TA208: Gastric cancer (HER2-positive metastatic) - trastuzumab
Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
Link  NICE TA34: Breast cancer - trastuzumab
 
Cytotoxic Drug Trastuzumab emtansine (Kadcyla®)
(S/C injection)
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High Cost Medicine
  • 100mg & 160mg powder for concentrate for solution for infusion
  • Approved for the treatment of HER2-positive advanced breast cancer after trastuzumab and a taxane in line with NICE and NHS England Commissioning Policy
  • Approved for human epidermal growth factor receptor 2 (HER2)‑positive early breast cancer in adults who have residual invasive disease in the breast or lymph nodes after neoadjuvant taxane-based and HER2‑targeted therapy in line with NICE
 
Link  NICE TA458 Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane
Link  NICE TA632: Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer
 
08.01.05  Tretinoin
Tretinoin
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Red
 
 
08.01.05  Vismodegib
08.02  Drugs affecting the immune response to top
 note 

Shared care guidelines are available for:

BlinatumomabBlack Triangle (Blincyto®)
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Red
  • Approved for use in previously treated Philadelphia-chromosome-negative acute lymphosblastic leukaemia in line with NICE and NHS England Commissioning Policy.
  • Approved for the treatment of acute lymphoblastic leukaemia in remission with minimal residual disease activity in line with NICE
  • Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

 

 
Link  NICE TA450 Blinatumomab for previously treated Philadelphia-chromosome-negative acute lymphoblastic leukaemia
Link  NICE TA589: Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity
 
Cytotoxic Drug Tepotinib (Tepmetko®)
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Red
High Cost Medicine
NHS England
  • Approved for treating advanced non-small-cell lung cancer (NSCLC) with METex14 skipping alterations in adults in line with NICE.
 
Link  NICE TA789: Tepotinib for treating advanced non-small-cell lung cancer with MET gene alterations
 
08.02  Immunosuppressant therapy
08.02.01  Antiproliferative immunosuppressants
Cytotoxic Drug Azathioprine
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Amber
  • An azathioprine 50mg in 5ml suspension (unlicensedunlicensed) is also available.
 
Link  North of Tyne, Gateshead and North Cumbria - Azathioprine Shared Care Agreement (Renal Transplant in adults)
Link  South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine in Neurology
 
Mycophenolate Mofetil
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Formulary
Amber
 
Link  MHRA Drug Safety Updates - Mycophenolate
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  South Tyneside & Sunderland APC Shared Care Guideline - Mycophenolate in Neurology
 
Mycophenolate Sodium (Myfortic®)
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Amber
  • Approved as second-line therapy in patients who do not tolerate mycophenolate mofetil.
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
08.02.02  Corticosteroids and other immunosuppressants
Azathioprine
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Red

For transplant indications

 
 
Ciclosporin (Neoral®)
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  • Neoral® is the preferred product for most indications.
  • Approved formulations include:
    • 10mg, 25mg, 50mg, and 100mg capsules;
    • 100mg in 1ml sugar free oral solution (oily).

 
 
Mycophenolate Mofetil
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Red
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
Mycophenolic Acid
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Red
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
Cytotoxic Drug Sirolimus
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Amber
  • Approved for renal transplantation in children and adolescents in line with NICE.
 
 
Cytotoxic Drug Tacrolimus
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Amber

Approved tacrolimus formulations include:

  • 500 microgram, 1mg & 5mg capsules (Prograf® & Adoport®).
  • 1mg in 1ml oral suspension (unlicensedunlicensed) - this replaces 0.5mg/ml oral
    suspension. 
  • 5mg in 1 ml concentrate for preparing IV infusion - approved for renal transplantation in children and adolescents in line with NICE.
  • 500microgram, 1mg, 3mg & 5mg MR capsules (Advagraf®) approved for use for prophylaxis of organ rejection in kidney and liver transplantation. Advagraf® is also approved for use in patients who are currently prescribed Prograf®, and de novo patients should be prescribed Adoport®.
  • 750microgram, 1 mg and 4 mg m/r tablets (Envarsus®)
    • approved for the treatment of renal and liver transplant patients who are suffering from neurotoxicity with other formulations or for patients requiring large doses of tacrolimus. 

 
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
Link  MHRA Drug Safety Alert (November 2017): Oral tacrolimus products: reminder to prescribe and dispense by brand name only RED drug also for non-transplant indications.
 
Voclosporin  (Lupkynis®)
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High Cost Medicine
NHS England
  • 7.9mg capsules
  • Approved with mycophenolate mofetil for treating lupus nephritis in adults in line with NICE and NHSe Specialised Commissioning Policy (SSC2540)
  • Only available from:
    • North Cumbria University Hospital NHS Trust
    • South Tyneside and Sunderland NHS Foundation Trust
    • South Tees Hopsitals NHS Foundation Trust
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust
 
Link  NICE TA882: Voclosporin with mycophenolate mofetil for treating lupus nephritis
 
Antithymocyte immunoglobulin (horse)  (Thymoglobuline®)
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Alternatives
Red
  • NETAG approved for aplastic anaemia in adults (unlicensedunlicensed).
 
 
Antithymocyte immunoglobulin (rabbit)  (Thymoglobuline®)
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Alternatives
Red
High Cost Medicine
  • Used in the management of transplant rejection.
 
 
Basiliximab
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Red
  • Approved for limited use in adult renal transplant patients with high risk of acute organ rejection.
  • Approved for severe graft versus host disease post haematopoietic stem cell transplantation.
  • Approved for induction therapy in renal transplantation in children and adolescents in with combinations that include ciclosporin in line with NICE.
 
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
 
Cytotoxic Drug Ciclosporin (Sandimmun®)
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Alternatives
Red
 
 
08.02.03  Anti-lymphocyte monoclonal antibodies
Alemtuzumab
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Red
NHS England
  • Alemtuzumab 30mg in 1ml concentrate for IV infusion is approved for use in, lymphocytic leukaemia & prevention of graft vs. host disease in bone marrow transplant patients, and high-risk kidney and pancreas transplantation.
  • Alemtuzumab 12mg in 1.2ml concentrate for IV infusion is approved for treating adults with active relapsing– remitting multiple sclerosis in line with NICE and NHS England commissioning policy. 

 

 
Link  NICE TA312: Alemtuzumab for relapsing‑remitting multiple sclerosis
Link  MHRA Drug Safety Update (Feb 2020): Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions
Link  MHRA Drug Safety Update (May 2019): Lemtrada (alemtuzumab) and serious cardiovascular and immune- mediated adverse reactions: new restrictions to use and strengthened monitoring requirements
 
Cytotoxic Drug AvelumabBlack Triangle (Bavencio®)
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Red
High Cost Medicine
NHS England
  • Approved for  for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy in adults in line with NICE
  • as an option for treating metastatic Merkel cell carcinoma in adults who have not had chemotherapy for metastatic disease in line with NICE
 
Link  NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
Link  NICE TA691: Avelumab for treating metastatic Merkel cell carcinoma
Link  NICE TA788: Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy
 
Obinutuzumab
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Red
High Cost Medicine
NHS England
  • Approved for use in chronic lymphocytic leukaemia in combination with chlorambucil in patients who have co-morbitities that make full‑dose fludarabine‑based therapy unsuitable for them, only if bendamustine‑based therapy is not suitable and the company provides obinutuzumab with the discount agreed in the patient access scheme in line with NICE (subject to NHS England funding).
  • Approved for the treatment of rituximab-refractory follicular lymphoma in combination bendamustine in line with NICE and NHS England Commissioning Policy
  • Approved with bendamustine for follicular lymphoma that has not responded or has progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen in adults in line with NICE
 
Link  NICE TA343: Obinutuzumab with chlorambucil for CLL
Link  NICE TA629: Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab
 
Ocrelizumab (Ocrevus®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for the treatment of relapsing-remitting multiple sclerosis in line with NICE

     

 
Link  NICE TA 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
Link  NICE TA585: Ocrelizumab for treating primary progressive multiple sclerosis
 
Ofatumumab  (Kesimpta®)
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Red
NHS England
BlueTeq
  • 20mg/0.4ml solution for injection (pre-filled pens)
    • Approved for the treatment of relapsing-remitting multiple sclerosis in adults with active diseases defined by clinical or imaging features in line with NICE

 

 
Link  NICE TA699: Ofatumumab for treating relapsing multiple sclerosis
 
Rituximab
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NICE have approved rituximab for the following indications:

  • First line use in NHL in combination with CHOP.
  • Maintenance therapy in follicular NHL that has responded to first line induction therapy with rituximab in combination with chemotherapy.
  • Stage III and IV follicular lymphoma in previously untreated people.
  • Replased or refractory follicular NHL.
  • Post-transplant lymphoproliferative disease.
  • First line use in CLL in combination with fludarabine and cyclophosphamide.
  • Combination with fludarabine and cyclophosphamide for relapsed or refractory CLL.
  • Autoimmune haematological conditions (where conventional treatments have failed)
  • Autoimmune haemolytic anaemia (AIHA), Evans syndrome, pure red cell aplasia (PRCA), & thrombocytopenia purpura (TTP).
  • Combination with bendamustine for first line use in CLL (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.Vasculitis (including Wegener’s granulomatosis in adults and children) that has not responded adequately to conventional treatment (e.g. corticosteroids, cyclophosphamide) in line with NICE and additional NHS England criteria.

NECDAG have approved rituximab for the following indications:

  • Treatment of NLPHL
  • Newly diagnosed mantle cell NHL in patients aged 
  • In combination with bendamustine for patients with CLL not fit for FCR chemotherapy or for patients who relapse within 2 years of FCR chemotherapy and not fit for alemtuzumab.
  • Salvage chemotherapy for patients relapsing > 12 months post 1st line therapy with R-CHOP.
  • Standard NHL induction regimen in patients who cannot be given an anthracycline. Rituximab with other chemotherapy regimens is an alternative treatment option e.g. DECC, CVP for this group of patients, as part of their first line therapy. Also in addition to the MACOP-B regimen for the small number of young patients with DLBCL, subtype Primary Mediastinal B cell Lymphoma.
  • Treatment of Hairy Cell Leukaemia (HCL) or  HCL varian (HCL-v) who:
    • relapse early after purine analogue therapy (< 2 years post treatment)
    • are refractory to purine analogues.

NTAG have approved rituximab for the following indications:

  • Treatment of immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children.

NHS England have approved rituximab for the following indications:

  • Treatment of immunobullous disease
  • Steroid Sensitive Nephrotic Syndrome in Children
  • Steroid Resistant Nephrotic Syndrome in Children
  • Acquired Haemophilia
  • Cytopenia Complicating Primary Immunodeficiency
  • Maintenance single agent therapy in FL, mantle cell lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphoma in line with (SSC1434) - 1.4g solution for sc injection.
  • Second line treatment for anti-NMDAR auto-immune encephalitis (all ages)
  • Treatment of refractory myasthenia gravis in a specialised neuroscience centre
  • Treatment of nodal/paranodal antibody positive inflammatory/autoimmune neuropathy in adults and post-pubescent children
  • Treatment of IgM paraproteinaemic demyelinating peripheral neuropathy in adults
  • Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
  • Treatment of Idiopathic Membranous Nephropathy (IMN)


North of Tyne, Gateshead and North Cumbria APC have approved rituxumab for the following indication:

  • Autoimmune hepatitis in patients who have failed or who are intolerant of therapies such as azathioprine, mycophenolate mofetil, corticosteroids and tacrolimus.

For musculoskeletal indications see chapter 10

 
Link  NICE TA137: Rituximab for the treatment of relapsed or refractory stage III or IV follicular non- Hodgkin’s lymphoma
Link  NICE TA174: Rituximab for the first-line treatment of chronic lymphocytic leukaemia
Link  NICE TA193: Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia
Link  NICE TA226: Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma
Link  NICE TA243: Rituximab for the first-line treatment of stage III-IV follicular lymphoma
Link  NTAG - Rituximab for ITP in adults and children
Link  MHRA Drug Safety Update (Dec 2014): Rituximab: progressive multifocal leukoencephalopathy in a patient
Link  MHRA Drug Safety Update (Dec 2013): Rituximab: screen for hepatitis B virus before treatment.
 
08.02.04  Other immunomodulating drugs to top
Daclizumab (Zinbryta®)
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Red
High Cost Medicine
  • 150mg subcutaneous injection
    • Approved for the treatment of highly active relapsing-remitting mutiple sclerosis that has failed to respond to other treatment in adults in line with NICE and NHS England Commissioning Policy. 
    • Subject to restricted use by EMA
 
Link  EMA Supporting Document restricting access to daclizumab
 
Diroximel fumarate (Vumerity®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 231mg capsules
    • Approved for treating relapsing-remitting multiple sclerosis in line with NICE
 
Link  NICE TA794: Diroximel fumarate for treating relapsing–remitting multiple sclerosis
 
Osimertinib (Tagrisso)
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Red
  • 40mg and 80mg tablet
  • Approved for the treatment of EGFR mutation-positive non-small-cell lung cancer in line with NICE
  • Approved for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults in line with NICE 

 

 
Link  NICE TA 653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
Link  NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
Link  NICE TA761 Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection
 
Ponesimod (Ponvory®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • 20mg tablets
    • Approved for treating relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features in adults in line with NICE


 

 
Link  NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis
 
Siponimod (Mayzent®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • 0.25mg and 2mg tablets
    • approved for treating secondary progressive multiple sclerosis in adults in line with NICE


 
Link  NICE TA656: Siponimod for treating secondary progressive multiple sclerosis
 
08.02.04  Interferon Alfa
Interferon Alfa-2b
(IntronA)
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Formulary
Red
 
 
Interferon Alfa-2b (Roferon-A®)
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Formulary
Red
High Cost Medicine
 
 
Peginterferon Alfa (Pegasys®, ViraferonPeg®)
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Red
  • Approved  for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies. 
 
Link  NICE CG165: Hepatitis B (chronic): diagnosis and management
Link  NICE TA106: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA200: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA300: Hepatitis C - peginterferon alfa
Link  NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon
Link  NICE TA96: Hepatitis B - peginterferon alfa
 
08.02.04  Interferon beta
Interferon Beta (Avonex®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Betaferon®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon beta (Extavia®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Rebif®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Peginterferon Beta-1a (Plegridy®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare

  • Approved treating relapsing–remitting multiple sclerosis in adults in line with NICE.

 
Link  NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
 
08.02.04  Interferon gamma
08.02.04  Aldesleukin
08.02.04  BCG bladder instillation to top
BCG 81mg vial (connaught)
(bladder instillation)
View adult BNF View SPC online View childrens BNF
Formulary
Red
 
 
08.02.04  Canakinumab
08.02.04  Dimethyl fumarate
Dimethyl fumarate (Tecfidera®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare

  • Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy. 

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  MHRA Drug safety Update (April 2016): Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy.
Link  MHRA Drug Safety Update (January 2021): Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
Link  MHRA Drug Safety Update (March 2015): Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Link  NICE TA320: Dimethyl fumarate for multiple sclerosis
 
08.02.04  Fingolimod
Fingolimod
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare

  • Approved for the treatment of highly active relapsing–remitting multiple sclerosis in line with NICE and NHS England Commissioning Policy.

  • Approved for patients who have progressed on glatiramer acetate and for those patients who are at high risk of progressive multifocal leukoencephalopathy (PML) in line with NHS EnglandClinical Commissioning Policy.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  Letter sent to healthcare professionals (Jan 2016): Fingolimod (Gilenya▼): risks related to effects on the immune system
Link  MHRA Drug Safety Update (Apr 2016): Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
Link  MHRA Drug Safety Update (Apr 2017): Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy
Link  MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Link  MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Link  MHRA Drug Safety Update (Jan 2021): Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
Link  MHRA Drug Safety Update (Sept 2019): Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Link  NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
 
08.02.04  Glatiramer acetate
Glatiramer Acetate
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare

  • Approved for treating multiple sclerosis in line with NICE and NHS Engand commissioning policy.

 
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
 
08.02.04  Histamine to top
08.02.04  Lenalidomide, pomalidomide, and thalidomide
Lenalidomide
View adult BNF View SPC online View childrens BNF
Formulary
Red
NHS England
  • Approved for multiple myeloma in line with NICE - approved for myelodysplastic syndrome with 5q deletion in line with NICE. 
  • Approved in combination with dexamethasone for previously untreated multiple myeloma in line with NICE 
  • Approved in combination with dexamethasone for multiple myeloma after one treatment with bortezomib
  • Approved for maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults in line with NICE
  • Approved with rituximab for previously treated follicular lymphoma (grade 1 to 3A) in adults in line with NICE

 



 
Link  Letter sent to healthcare professionals (Nov 2016): lenalidomide (Revlimid▼): new advice about viral reactivation
Link  MHRA Drug Safety Update (Feb 2011): Lenalidomide: risk of thrombosis and thromboembolism
Link  MHRA Drug Safety Update (Jan 2013): Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions
Link  MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Link  MHRA Drug Safety Update (Nov 2011): Lenalidomide (Revlimid▼): update on risk of second primary malignancy
Link  NICE TA171: Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies
Link  NICE TA27: Lenalidomide with rituximab for previously treated follicular lymphoma
Link  NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
Link  NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib
Link  NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma
Link  NICE TA680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma
 
Pomalidomide (Imnovid®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
  • For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib in line with NICE and NHS Commissioning Policy
 
Link  NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
 
Thalidomide
View adult BNF View SPC online View childrens BNF
Formulary
Red
  • Approved in combination with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma in line with NICE. 
  • Approved for the treatment of bleeding from bowel angiodysplasia in patients with an inherited/acquired bleeding disorder on specialist advice only.
  • Approved for the treatment of severe epistaxis as a result of hereditary haemorrhagic telangiectasia (HHT) who have failed all other treatments.
 
Link  Letter sent to healthcare professionals in June 2016: Thalidomide Celgene®: New important advice regarding viral reactivation and pulmonary hypertension
Link  MHRA Drug Safety Update (December 2015): Thalidomide: reduced starting dose in patients older than age 75 years
Link  MHRA Drug Safety Update (July 2011): Thalidomide: risk of arterial and venous thromboembolism
Link  MHRA Drug Safety Update (May 2013): Thalidomide: risk of second primary malignancies
Link  MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Link  NICE TA228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
 
08.02.04  Mifamurtide
Mifamurtide
View adult BNF View SPC online View childrens BNF
Formulary
Red
  • Approved for high-grade resectable non-metastatic osteosarcoma in line with NICE.
 
Link  NICE TA235: Osteosarcoma - mifamurtide: guidance
 
08.02.04  Natalizumab
Natalizumab
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare

  • Approved for rapidly evolving severe relapsing remitting multiple sclerosis in line with NICE and NHS England commissioning policy.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  MHRA Drug Safety Update (Apr 2016): Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy— updated advice to support early detection
Link  MHRA Drug Safety Update (May 2011): Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
Link  NICE TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis
 
08.02.04  Teriflunomide
Teriflunomide
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
Homecare

  • Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  NICE TA303: Teriflunomide for treating relapsing–remitting multiple sclerosis
 
08.03  Sex hormones and hormone antagonists in malignant disease to top
08.03.01  Oestrogens
Diethylstilbestrol
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
  • Should be initiated with specialist advice.
 
 
08.03.02  Progestogens
Medroxyprogesterone Acetate
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
  • Approved formualtion include 100mg, 200mg, and 400mg tablets. 
  • Medroxyprogesterone acetate 500mg in 2.5ml injection is also approved. 
 
 
Megestrol Acetate
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
Norethisterone
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
08.03.03  Androgens
08.03.04  Hormone antagonists
08.03.04.01  Breast cancer to top
Abemaciclib (Verzenios®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
BlueTeq

  • 50mg, 100mg and 150mg tablets

  • Approved as an options for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults in line with NICE

  • Approved with fulvestrant for treating hormone receptor-positive, HER2 negative advanced breast cancer after endocrine therapy in line with NICE 


 

 
Link  MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases
Link  NICE TA 563: Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
Link  NICE TA725: Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
Link  NICE TA810: Abemaciclib with endocrine therapy for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence
 
Alpelisib (Piqray®)
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 50mg, 150mg and 200mg tablets
  • Approved with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated, locally advanced or metastatic breast cancer in adults in line with NICE
 
Link  NICE TA816: Alpelisib with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer
 
Anastrozole
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
Exemestane
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
Fulvestrant (Faslodex®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
 
Link  NICE TA239: Fulvestrant for the treatment of locally advanced or metastatic breast cancer
 
Letrozole
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
Palbociclib (Ibrance®)
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
  • 75mg, 100mg & 125mg capsules
  • Approved for use with an aromatase inhibitor for the treatment of previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in line with NICE
  • Approved with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy in line with NICE
 
Link  NICE TA495: Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
Link  NICE TA836: Palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
Link  MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases
 
Raloxifene
View adult BNF View SPC online View childrens BNF
Formulary
Green plus

60mg tablets

 
 
Ribociclib (Kisqali®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
  • 200mg tablets
  • Approved for use with an aromatase inhibitor for the treatment of previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in line with NICE and NHS England Commissioning Policy
  • Approved for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have had previous endocrine therapy in line with NICE

 

 
Link  NICE TA496: Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
Link  NICE TA687: Ribociclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
Link  MHRA Drug Safety Update (June 2021): CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼): reports of interstitial lung disease and pneumonitis, including severe cases
 
Tamoxifen
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
  • Approved formulations include:
    • 10mg and 20mg tablets;
    • 10mg in 5ml sugar free oral solution.

 
 
08.03.04.02  Prostate cancer and gonadorelin analogues
Radium-223 dichloride
(Xofigo®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
  • Provided by radiotherapy department in accordance with NICE
 
Link  NICE TA412: Radium-223 dichloride for treating hormone-relapsed prostate cancer with bone metastases
Link  MHRA Drug Safety Update (December 2017): Radium-223 dichloride (Xofigo▼): do not use in combination with abiraterone and prednisone/prednisolone, following clinical trial signal of increased risk of death and fractures  
 
08.03.04.02  Gonadorelin analogues
 note 

Clinicians are encouraged to prescribe the least expensive product that is clinically appropriate.

Goserelin
View adult BNF View SPC online View childrens BNF
First Choice
Green plus
  • Approved formulations include 3.6mg and 10.8mg implants.
 
Leuprorelin Acetate
View adult BNF View SPC online View childrens BNF
First Choice
Green plus
  • Approved formulations include leuprorelin 3.75mg & 11.25mg prefilled syringes.
 
Triptorelin
View adult BNF View SPC online View childrens BNF
First Choice
Green plus

  • Approved formulations include triptorelin 3mg, 11.25mg and 22.5mg IM injection for the treatment of prostate cancer

  • Please note for the treatment of precocious puberty please refer to Chapter 6 Drugs affecting gonadotrophins

 
Degarelix
View adult BNF View SPC online View childrens BNF
First Choice
Green plus
  • Approved formulations include 80mg and 120mg vials (with diluent).
  • Approved for the first line treatment of advanced hormone dependant prostate cancer with a PSA > 20ng/l at presentation 
    • -approved as an option for treating advanced hormone-dependent prostate cancer in people with spinal metastases in line with NICE.

 
Buserelin
(Prostate)
View adult BNF View SPC online View childrens BNF
Alternatives
Green plus
  • Approved formulations include:
    • 5mg in 5ml injection;
    • 150 microgram metered dose nasal spray.

 
 
08.03.04.02  Anti-androgens
Abiraterone
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
  • Approved for castration-resistant metastatic prostate cancer in line with NICE.
  • Approved for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated in line with NICE and NHS England Commissioning Policy.
 
Link  NICE TA259: Abiraterone for castration resistant prostate cancer
Link  NICE TA387:Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
 
Apalutamide  (Erleada®)
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red
BlueTeq
  • 60mg tablets
  • Approved for treating hormone‑relapsed non‑metastatic prostate cancer that is at high risk of metastasising in adults in line with NICE
  • Approved for treating hormone-sensitive metastatic prostate cancer in adults in line with NICE, only if:
    • docetaxel is not suitable

 

 
Link  NICE TA740: Apalutamide with androgen deprivation therapy for treating high-risk hormone-relapsed non-metastatic prostate cancer
Link  NICE TA741: Apalutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer
 
Bicalutamide
View adult BNF View SPC online View childrens BNF
Formulary
Green plus

Initiate with specialist advice.

 
 
Cyproterone
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
Darolutamide (Nubeqa®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 300mg tablets
  • Approved for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease in line with NICE
  • Approved with andorgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer in line with NICE and NHSE Specialised Commissioning guidance

 

 
Link  NICE TA660: Darolutamide with androgen deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer
Link  NICE TA903: Darolutamide with androgen deprivation therapy and docetaxel for treating hormone-sensitive metastatic prostate cancer
 
Enzalutamide
View adult BNF View SPC online View childrens BNF
Formulary
Red
  • Approved for use in adults with metastatic hormone-relapsed prostate cancer, who have not had chemotherapy in line with NICE.
  • Approved for treating hormone-sensitive metastatic prostate cancer in line with NICE
 
Link  NICE TA316: Enzalutamide for prostate cancer
Link  NICE TA377: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
Link  NICE TA712: Enzalutamide for treating hormone-sensitive metastatic prostate cancer
 
Flutamide
(UNDER REVIEW)
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
08.03.04.02  Radiopharmaceuticals
08.03.04.03  Somatostatin analogues to top
Lanreotide
View adult BNF View SPC online View childrens BNF
Formulary

  • Approved formulation include lanreotide 30mg long-acting injection and lanreotide 60mg, 90mg, and 120mg autogel injections.

    Existing patients 
    Green Traffic Light  for acromegaly, neuroendocrine tumour and carcinoid. 
    New patients (commenced treatment after July 2019)
    Red Traffic Light  for acromegaly, neuroendocrine tumour and carcinoid.


 

 
Link  LANREOTIDE AND OCTREOTIDE - Information for Treatment of Adults with acromegaly or neuroendocrine tumours in Primary Care
 
Octreotide
View adult BNF View SPC online View childrens BNF
Formulary

  • Approved formulations include octreotide 50microgram, 100microgram, and 500 microgram in 1ml, and 1mg in 5ml injections, and octreotide 10mg, 20mg and 30mg long-acting injections.
    Existing patients 
    Green Traffic Light  for acromegaly, neuroendocrine tumour and carcinoid. 
    New patients (commenced treatment after July 2019)
    Red Traffic Light  for acromegaly, neuroendocrine tumour and carcinoid.



  • Green Traffic Light Approved for the management of GI secretions in end of life care


 

 
Link  LANREOTIDE AND OCTREOTIDE - Information for Treatment of Adults with acromegaly or neuroendocrine tumours in Primary Care
 
Pasireotide (Signifor®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
  • Approved for the treatment of Cushing’s disease in line with NHS England Policy.
 
Link  Clinical Commissioning Policy: Pasireotide diaspartate: an injectable medical therapy for the treatment of Cushings’ Disease
 
 ....
 Non Formulary Items
Ciclosporin  (Deximune®)

View adult BNF View SPC online View childrens BNF
Non Formulary
Mosunetuzumab  (Lunsumio®)

View adult BNF View SPC online View childrens BNF
Non Formulary
Not Recomended
  • 1mg/1ml and 30mg/30ml concentrate for solution for infusion
Link  NICE TA892: Mosunetuzumab for treating relapsed or refractory follicular lymphoma
Ripretinib  (Qinlock® )

View adult BNF View SPC online View childrens BNF
Non Formulary
Not Recomended
  • 50mg tablet
Link  NICE TA881: Ripretinib for treating advanced gastrointestinal stromal tumour after 3 or more treatments
Tafasitamab  (Minjuvi® )

View adult BNF View SPC online View childrens BNF
Non Formulary
Not Recomended
  • 200mg powder for concentrate for solution for infusion
Link  NICE TA883: Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma
  
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

netFormulary