North East and North Cumbria
ICS Formulary
 
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8 Malignant disease and immunosuppression
08-01-05 Protein kinase inhibitors

Afatinib
Formulary

  • 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

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Axitinib  Inlyta®
Formulary
  • 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

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Bosutinib Bosulif®
Formulary
  • 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

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Brigatinib Alunbrig®
Formulary
  • 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

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Cabozantinib Cometriq®
Formulary
  • 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
  • Approved with nivolumab (Opdivo) for untreated advanced renal cell carcinoma in adults in line with NICE
Link  NICE TA463 Cabozantinib for previously treated advanced renal cell carcinoma
Link  NICE TA516: Cabozantinib for treating medullary thyroid cancer
Link  NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma
Link  NICE TA849: Cabozantinib for previously treated advanced hepatocellular carcinoma
Link  NICE TA964: Cabozantinib with nivolumab for untreated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

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Ceritinib
Formulary
  • 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

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Crizotinib
Formulary
  • 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

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Dabrafenib  Tafinlar®
Formulary
  • 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
  • Approved with trametinib (Spexotras) for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over 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
Link  NICE TA977: Dabrafenib with trametinib for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over

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Dasatinib Sprycel®
Formulary
  • 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

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Encorafenib Braftovi®
Formulary

  • 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

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Everolimus Afinitor®, Votubia®
Formulary
  • 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

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Gefitinib
Formulary
  • 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

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Ibrutinib Imbruvica®
Formulary
  • 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

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Imatinib
Formulary
  • 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

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Lapatinib Tyverb®
Formulary
Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer

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Lenvatinib Kisplyx®
Formulary
  • 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

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Mobocertinib
Formulary
Link  NICE TA855: Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy

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Nilotinib Tasigna®
Formulary
  • 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

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Nintedanib
Formulary
  • 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

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Pazopanib Votrient®
Formulary
  • 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

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Pemigatinib Pemaryze®
Formulary
  • 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

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Ponatinib Iclusig®
Formulary
  • 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

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Regorafenib Stivarga®
Formulary
  • 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

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Ruxolitinib
Formulary
  • 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

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Sorafenib Nexavar®
Formulary
  • 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.
  • Approved as maintenance for adults with FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukaemia (AML) undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) in line with NHS England Specialised Commissioning Policy
    • Only available at The Newcastle upon Tyne Hospitals NHS Trust
Link  NHS England Specialised Commissioning Policy: Sorafenib maintenance for adults with FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukaemia (AML) undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT)
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

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Sunitinib  Sutent®
Formulary
  • 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

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Temsirolimus Torisel®
Formulary

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Trametinib
Formulary
  • 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

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Tucatinib Tukysa®
Formulary
  • 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

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Vemurafenib
Formulary
  • Approved for 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

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Zanubrutinib Brukinsa®
Formulary
  • 80mg capsule
Link  NICE TA833: Zanubrutinib for treating Waldenstrom’s macroglobulinaemia

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Zanubrutinib Brukinsa®
Non Formulary
  • Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal)
Link  NICE TA978: Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal)

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