8.1.5 Other antineoplastic drugs

Hydroxycarbamide
  • Capsules 500mg (100 = £12.14)

Notes

  1. Refer to individual shared care guidelines for use in myeloproliferative disorders
  2. For all other indications, prescribing should remain in secondary care
Arsenic trioxide
  • Solution for infusion 1mg in 1ml

Notes

  1. NICE TA526: Arsenic trioxide is recommended, within its marketing authorisation, as an option for inducing remission and consolidation in acute promyelocytic leukaemia (characterised by the presence of the t[15;17] translocation or the PML/RAR-alpha gene) in adults (Jun 2018)
Autologous anti-CD19-transduced CD3+ cells
  • 0.4 – 2 × 108 cells dispersion for infusion

Notes

  1. NICE TA677: Autologous anti-CD19-transduced CD3+ cells (Tecartus) is recommended for use within the Cancer Drugs Fund as an option for relapsed or refractory mantle cell lymphoma in adults who have previously had a Bruton's tyrosine kinase (BTK) inhibitor (Feb 2021)
Axicabtagene ciloleucel
  • Dispersion for infusion 0.4 – 2 x 108 cells

Notes

  • NICE TA559: Axicabtagene ciloleucel therapy (Yescarta) is recommended as an option for treating relapsed or refractory diffuse large B‑cell lymphoma or primary mediastinal large B‑cell lymphoma in adults after 2 or more systemic therapies (Jan 2019)
Bevacizumab
  • Intravitreal injection 5mg/0.2ml (unlicensed preparation)

Indications

  • Neovascular (wet) age related macular degeneration
  • Prior to vitrectomy in patients with proliferative diabetic retinopathy
  • Radiation maculopathy
  • Rubeosis iridis and neovascular glaucoma (see notes below)

Notes

  1. The decision to offer bevacizumab intravitreal injection is at the discretion of the treating clinician. The patient must be made fully aware that bevacizumab intravitreal injection is an unlicensed preparation and give informed consent to its use
  2. The routine commissioning of bevacizumab is accepted in Devon for the first line treatment of neovascular (wet) age related macular degeneration (see Commissioning Policy for more details)
  3. The routine commissioning of bevacizumab is accepted in Devon for use prior to vitrectomy in patients with proliferative diabetic retinopathy (see Commissioning Policy for more details)
  4. The routine commissioning of bevacizumab intravitreal injection is accepted in Devon for the management of radiation maculopathy (see Commissioning Policy for more details)
  5. The routine commissioning of bevacizumab intravitreal injection is accepted in Devon for the management of rubeosis iridis and neovascular glaucoma only in the following circumstances (see Commissioning Policy for more details):
    1. As an adjunct to pan-retinal laser photocoagulation where laser alone has not been effective, or
    2. As an adjunct to pan-retinal laser photocoagulation if significant neovascularisation of the iridocorneal angle is already present, or
    3. In the presence of media opacities which prevent the use of pan-retinal laser photocoagulation
  6. NICE TA214: Bevacizumab in combination with a taxane is not recommended for the first-line treatment of metastatic breast cancer (Feb 2011)
  7. NICE TA263: Bevacizumab in combination with capecitabine is not recommended for the first-line treatment of metastatic breast cancer (Aug 2012)
  8. NICE TA118: Bevacizumab in combination with 5-fluorouracil plus folinic acid, with or without irinotecan, is not recommended for the first-line treatment of metastatic colorectal cancer (Jan 2007)
  9. NICE TA242: Bevacizumab in combination with non-oxaliplatin (fluoropyrimidine-based) chemotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy (Jan 2012)
  10. NICE TA212: Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine is not recommended for the treatment of metastatic colorectal cancer (Dec 2010)
  11. NICE TA284: Bevacizumab in combination with paclitaxel and carboplatin is not recommended for first-line treatment of advanced ovarian cancer (May 2013)
  12. NICE TA285: Bevacizumab in combination with gemcitabine and carboplatin is not recommended for treating people with the first recurrence of platinum-sensitive advanced ovarian cancer (May 2013)
  13. NICE TA693: Olaparib (Lynparza) plus bevacizumab (Avastin) is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment of advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults (Apr 2021) when:
    1. there has been a complete or partial response after first-line platinum-based chemotherapy plus bevacizumab, and
    2. the cancer is associated with homologous recombination deficiency (HRD)
    3. It is recommended only if the conditions in the managed access agreement for olaparib are followed
  14. NICE TA178: Bevacizumab, sorafenib and temsirolimus are not recommended as first-line treatment options for people with advanced and/or metastatic renal cell carcinoma (Aug 2009)
  15. MHRA Drug Safety Update (Jan 2011) Bevacizumab and sunitinib: risk of osteonecrosis of the jaw (ONJ)
    1. Treatment with bevacizumab or sunitinib may be a risk factor for the development of ONJ
    2. Patients treated who have previously received, or are treated concurrently with, bisphosphonates may be particularly at risk
    3. Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib; invasive dental procedures should be avoided, if possible, in patients treated with bevacizumab or sunitinib who have previously received, or who are receiving, intravenous bisphosphonates
  16. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Cetuximab
  • IV infusion 5mg/ml

Notes

  1. NICE TA145: Cetuximab (Erbitux) in combination with radiotherapy is recommended as a treatment option only for patients with locally advanced squamous cell cancer of the head and neck whose Karnofsky performance-status score is 90% or greater and for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (Jun 2008).
  2. NICE TA242: Cetuximab (Erbitux) monotherapy or combination chemotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy (Jan 2012)
  3. NICE TA439: Cetuximab (Erbitux) is recommended as an option for previously untreated epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in adults in combination with (Nov 2017):
    1. 5‑fluorouracil, folinic acid and oxaliplatin (FOLFOX) or
    2. 5‑fluorouracil, folinic acid and irinotecan (FOLFIRI)
  4. NICE TA473: Cetuximab (Erbitux) in combination with platinum-based chemotherapy is recommended as an option for treating recurrent or metastatic squamous cell cancer of the head and neck in adults, only when the criteria of the NICE TA are met (Aug 2017)
  5. NICE TA668: Encorafenib (Braftovi) plus cetuximab (Erbitux) is recommended, within its marketing authorisation, as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment (Jan 2021)
Dacarbazine
  • Powder for solution for infusion 500mg, 1g vial
  • Powder for solution for injection 100mg, 200mg
Eribulin
  • 0.44 mg/ml solution for injection

Notes

  1. NICE TA423: Eribulin is recommended for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens (Dec 2016)
  2. NICE TA515: Eribulin is not recommended for treating locally advanced or metastatic breast cancer in adults who have had only 1 chemotherapy regimen (Mar 2018)
Gilteritinib
  • Tablets 40mg

Notes

  1. NICE TA642: Gilteritinib (Xospata) monotherapy is recommended as an option for treating relapsed or refractory FLT3‑mutation-positive acute myeloid leukaemia (AML) in adults (Aug 2020)
    1. Gilteritinib should not be given as maintenance therapy after a haematopoietic stem cell transplant
Neratinib
  • Tablets 40mg

Notes

  1. NICE TA612: Neratinib (Nerlynx) is recommended as an option for the extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑positive early stage breast cancer in adults, only when the criteria of the NICE TA are met (Nov 2019)
Niraparib
  • Capsules 100mg

Notes

  1. NICE TA528: Niraparib (Zejula) is recommended as an option for treating relapsed, platinum-sensitive high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to the most recent course of platinum-based chemotherapy in adults, only when the criteria of the NICE TA are met (Jul 2018)
  2. NICE TA673: Niraparib (Zejula) is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment for advanced (FIGO stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer after response to first-line platinum-based chemotherapy in adults (Feb 2021)
    1. It is recommended only if the conditions in the managed access agreement for niraparib are followed
  3. MHRA Drug Safety Update (Oct 2020): Niraparib (Zejula): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment
Olaparib
  • Tablets 100mg, 150mg

Notes

  1. NICE TA598: Olaparib (Lynparza) is recommended as an option for the maintenance treatment of BRCA mutation‑positive, advanced (FIGO stages 3 and 4), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults (Aug 2019)
  2. NICE TA620: Olaparib (Lynparza) is recommended as an option for the maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose disease has responded to platinum-based chemotherapy, only when the criteria of the NICE TA are met (Jan 2020)
  3. NICE TA693: Olaparib (Lynparza) plus bevacizumab (Avastin) is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment of advanced (International Federation of Gynecology and Obstetrics [FIGO] stages 3 and 4) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults (Apr 2021) when:
    1. there has been a complete or partial response after first-line platinum-based chemotherapy plus bevacizumab, and
    2. the cancer is associated with homologous recombination deficiency (HRD)
    3. It is recommended only if the conditions in the managed access agreement for olaparib are followed
Panitumumab
  • Concentrate for solution for infusion 20mg/ml

Notes

  1. NICE TA439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer (Nov 2017)
Pegaspargase
  • Solution for injection vials 750units in 1ml

Notes

  1. NICE TA408: Pegaspargase (Oncaspar), as part of antineoplastic combination therapy, is recommended as an option for treating acute lymphoblastic leukaemia in children, young people and adults only when they have untreated newly diagnosed disease (Sept 2016)
Pentostatin
  • Powder for solution for injection 10mg
Pertuzumab
  • Concentrate for solution for infusion vials 30mg in 1ml

Notes

  1. NICE TA424: Pertuzumab (Perjeta), in combination with trastuzumab and chemotherapy, is recommended as an option for the neoadjuvant treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer; that is, in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence (Dec 2016)
  2. NICE TA509: Pertuzumab (Perjeta), in combination with trastuzumab and docetaxel, is recommended for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti HER2 therapy or chemotherapy for their metastatic disease (Mar 2018)
  3. NICE TA569: Pertuzumab (Perjeta), with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only when the criteria of the NICE TA are met (Mar 2019)
Rucaparib
  • Tablets 200mg, 250mg, 300mg

Notes

  1. NICE TA611: Rucaparib (Rubraca) is recommended for use within the Cancer Drugs Fund as an option for maintenance treatment of relapsed platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy in adults (Nov 2019)
Talimogene laherparepvec
  • Solution for injection vials 1mega u in 1ml
  • Solution for injection vials 100mega u in 1ml

Notes

  1. NICE TA410: Talimogene laherparepvec (Imlygic) is recommended, in adults, as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs, only if (Sept 2016):
    1. treatment with systemically administered immunotherapies is not suitable
Tisagenlecleucel
  • 1.2 x 106 – 6 x 108 cells dispersion for infusion

Notes

  1. NICE TA554: Tisagenlecleucel therapy (Kymriah) is recommended as an option for treating relapsed or refractory B‑cell acute lymphoblastic leukaemia in people aged up to 25 years, only when the criteria of the NICE TA are met (Dec 2018)
  2. NICE TA567: Tisagenlecleucel therapy (Kymriah) is recommended as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies (Mar 2019)
Temozolomide
  • Capsules 5mg, 20mg, 100mg, 140mg, 180mg, 250mg

Notes

  1. NICE TA121: Carmustine implants and temozolomide recommended for the treatment of newly diagnosed high-grade glioma (Jun 2007)
  2. NICE TA23: Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer) (Mar 2016)
Trifluridine–tipiracil
  • Tablets 15mg/6.14mg, 20mg/8.19mg

Notes

  1. NICE TA405: Trifluridine–tipiracil (Lonsurf) is recommended as an option for treating metastatic colorectal cancer, that is (Aug 2016):
    1. in adults who have had previous treatment with available therapies including fluoropyrimidine-, oxaliplatin- or irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and anti-epidermal growth factor receptor (EGFR) agents, or when these therapies are not suitable
  2. NICE TA669: Trifluridine–tipiracil (Lonsurf) is not recommended within its marketing authorisation, for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more systemic treatment regimens (Jan 2021)
Necitumumab
  • NICE TA411: Necitumumab, in combination with gemcitabine and cisplatin, is not recommended for untreated advanced or metastatic squamous non-small-cell lung cancer (Sept 2016)
Vismodegib
  • NICE TA489: Vismodegib is not recommended for treating symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy, in adults. (Nov 2017)
Procarbazine
  • Capsules 50mg

Protein kinase inhibitors

Acalabrutinib
  • Capsules 100mg

Notes

  1. NICE TA689: Acalabrutinib for treating chronic lymphocytic leukaemia (Apr 2021)
    1. Acalabrutinib (Calquence) as monotherapy is recommended as an option for untreated chronic lymphocytic leukaemia (CLL) in adults (Apr 2021), only if:
      • there is a 17p deletion or TP53 mutation, or
      • there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR) is unsuitable, and
      • the company provides the drug according to the commercial arrangement
    2. Acalabrutinib (Calquence) as monotherapy is recommended, within its marketing authorisation, as an option for previously treated CLL in adults
      • It is recommended only if the company provides the drug according to the commercial arrangement
Afatinib dimaleate
  • Tablets 20mg, 30mg, 40mg, 50mg

Notes

  1. NICE TA310: Afatinib (Giotrif) is recommended as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults (Aug 2018)
Alectinib hydrochloride
  • Capsules 150mg

Notes

  1. NICE TA536: Alectinib (Alecensa) is recommended as an option for untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults (Aug 2018)
Axitinib
  • Tablets 1mg, 3mg, 5mg, 7mg

Notes

  1. NICE TA333: Axitinib (Inlyta) is recommended as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first‑line tyrosine kinase inhibitor or a cytokine (Feb 2015)
  2. NICE TA645: Avelumab (Bavencio) with axitinib (Inlyta) is recommended for use within the Cancer Drugs Fund as an option for untreated advanced renal cell carcinoma in adults (Sept 2020)
  3. NICE TA650: Pembrolizumab (Keytruda) with axitinib (Inlyta) is not recommended, within its marketing authorisation, for untreated advanced renal cell carcinoma in adults (Sept 2020)
  4. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Binimetinib
  • Tablets 15mg

Notes

  1. NICE TA562: Encorafenib (Braftovi) with binimetinib (Mektovi) is recommended as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults (Feb 2019)
Bosutinib monohydrate
  • Tablets 100mg, 500mg

Notes

  1. NICE TA401: Bosutinib (Bosulif) is recommended as an option for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, only when the criteria of the NICE TA are met (Aug 2016)
  2. Not routinely commissioned. It has been approved for use in certain conditions where all the criteria set out by the Cancer Drugs Fund are met.
Brigatinib
  • Tablets 30mg, 90mg, 180mg

Notes

  1. NICE TA571: Brigatinib (Alunbrig) is recommended for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib (Mar 2019)
  2. NICE TA670: Brigatinib (Alunbrig) is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor in adults (Jan 2021)
Cabozantinib
  • Tablets 20mg, 40mg, 60mg
  • Capsules 20mg, 80mg

Notes

  1. NICE TA463: Cabozantinib (Cabometyx) is recommended as an option for treating advanced renal cell carcinoma in adults after vascular endothelial growth factor (VEGF)-targeted therapy (Aug 2017)
  2. NICE TA516: Cabozantinib (Cometriq) is recommended as an option for treating progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease (Mar 2018)
  3. NICE TA542: Cabozantinib (Cabometyx) is recommended for adults with untreated advanced renal cell carcinoma that is intermediate‑ or poor‑risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria (Oct 2018)
  4. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection inpatients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Ceritinib
  • Capsules 150mg

Notes

  1. NICE TA395: Ceritinib recommended for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer (Jun 2016)
  2. NICE TA500: Ceritinib for untreated ALK-positive non-small-cell lung cancer (Jan 2018)
Crizotinib
  • Capsules 200mg, 250mg

Notes

  1. NICE TA406: Crizotinib is recommended for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer (Sept 2016)
  2. NICE TA422: Crizotinib is recommended for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer (Dec 2016)
  3. NICE TA529: Crizotinib is recommended for use within the Cancer Drugs Fund as an option for treating ROS1‑positive advanced non-small-cell lung cancer (NSCLC) in adults, only if the conditions in the managed access agreement are followed. (Jul 2018)
  4. Not routinely commissioned for other indications. It has been approved for use in certain conditions where all the criteria set out by the Cancer Drugs Fund are met.
Dabrafenib
  • Capsules 50mg, 75mg

Notes

  1. NICE TA321: Dabrafenib (Trafinlar) is recommended as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma (Oct 2014)
  2. NICE TA396: Trametinib (Mekinst) in combination with Dabrafenib (Trafinlar) is recommended as an option for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation only (Jun 2016)
  3. NICE TA544: Dabrafenib (Trafinlar) with Trametinib (Mekinst) is recommended as an option for the adjuvant treatment of resected stage III, BRAF V600 mutation-positive melanoma in adults (Oct 2018)
Dacomitinib monohydrate
  • Tablets 15mg, 30mg, 45mg

Notes

  1. NICE TA595: Dacomitinib (Vizimpro) is recommended as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults (Aug 2019)
Dasatinib
  • Tablets 20mg, 50mg, 80mg, 100mg, 140mg

Notes

  1. NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia (Dec 2016):
    1. Dasatinib (Sprycel), nilotinib (Tasigna) are recommended as options for treating only chronic- or accelerated-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults if they cannot have imatinib, or their disease is imatinib-resistant
  2. NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia (Dec 2016):
    1. Dasatinib (Sprycel) and nilotinib (Tasigna) are recommended as options for untreated chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults
Encorafenib
  • Capsules 50mg, 75mg

Notes

  1. NICE TA562: Encorafenib (Braftovi) with binimetinib (Mektovi) is recommended as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults (Feb 2019)
  2. NICE TA668: Encorafenib (Braftovi) plus cetuximab (Erbitux) is recommended, within its marketing authorisation, as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment (Jan 2021)
Entrectinib
  • Capsules 100mg, 200mg

Notes

  1. NICE TA643: Entrectinib (Rozlytrek) is recommended, within its marketing authorisation, as an option for treating ROS1-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had ROS1 inhibitors (Aug 2020)
  2. NICE TA644: Entrectinib (Rozlytrek) is recommended for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children 12 years and older (Aug 2020), if:
    1. the disease is locally advanced or metastatic or surgery could cause severe health problems and
    2. they have not had an NTRK inhibitor before and
    3. they have no satisfactory treatment options
Erlotinib
  • Tablets 25mg, 100mg, 150mg

Notes

  1. NICE TA162: Erlotinib recommended for the treatment of non-small-cell lung cancer (Nov 2008)
  2. NICE TA227: Erlotinib monotherapy is not recommended for the maintenance treatment of non-small cell lung cancer (Jun 2011)
  3. NICE TA258: Erlotinib recommended for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small-cell lung cancer (Jun 2012)
  4. NICE TA374: Erlotinib and gefitinib are recommended for treating non-small-cell lung cancer that has progressed after prior chemotherapy (Dec 2015)
Gefitinib
  • Tablets 250mg

Notes

  1. NICE TA192: Gefitinib is recommended for the first-line treatment of locally advance or metastatic non-small-cell lung cancer (Jul 2010)
  2. NICE TA374: Erlotinib and gefitinib are recommended for treating non-small-cell lung cancer that has progressed after prior chemotherapy (Dec 2015)
Ibrutinib
  • Capsules 140mg

Notes

  1. NICE TA429: Ibrutinib is recommended within its marketing authorisation as an option for treating chronic lymphocytic leukaemia in adults (Jan 2017)
  2. NICE TA491: Ibrutinib is recommended for treating Waldenstrom's macroglobulinaemia (Nov 2017)
  3. NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma (Jan 2018)
Idelalisib
  • Tablets 100mg, 150mg

Notes

  1. NICE TA359: Idelalisib (Zydelig) in combination with rituximab, is recommended (Oct 2015):
    1. for untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation or
    2. for chronic lymphocytic leukaemia in adults when the disease has been treated but has relapsed within 24 months
  2. NICE TA604: Idelalisib (Zydelig) is not recommended for treating follicular lymphoma that has not responded to 2 prior lines of treatment in adults (Oct 2019)
Imatinib
  • Tablets 100mg, 400mg

Notes

  1. NICE TA70: Imatinib is recommended for chronic myeloid leukaemia (Oct 2003)
  2. NICE TA86: Imatinib is recommended for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours (Oct 2004)
  3. NICE TA209: Imatinib is not recommended for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours (Nov 2010)
  4. NICE TA251: Dasatinib (not recommended), nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia (Apr 2012)
  5. NICE TA326: Imatinib is recommended as a possible treatment for up to 3 years, for people who had gastrointestinal stromal tumours that were removed by surgery, when there is a high risk that the tumour may come back. (Nov 2014)
  6. NICE TA426: Dasatinib, nilotinib and imatinib recommended for untreated chronic myeloid leukaemia (Dec 2016)
  7. NICE TA425: Dasatinib, nilotinib and high-dose imatinib recommended for treating imatinib-resistant or intolerant chronic myeloid leukaemia (Dec 2016)
Lapatinib ditosylate monohydrate
  • NICE TA257: Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone-receptor-positive breast cancer that over expresses HER2 (Jun 2012):
    • Lapatinib (Tyverb) in combination with an aromatase inhibitor is not recommended for first-line treatment in postmenopausal women with metastatic hormone-receptor-positive breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2)
Lenvatinib mesilate
  • Capsules 4mg, 10mg

Notes

  1. NICE TA498: Lenvatinib (Kisplyx) plus everolimus is recommended as an option treating advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, only if their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 (Jan 2018)
  2. NICE TA535: Lenvatinib (Lenvima) and sorafenib (Nexavar) are recommended as options for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only when the criteria of the NICE TA are met (Aug 2018)
  3. NICE TA551: Lenvatinib (Lenvima) is recommended as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults, only if they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Dec 2018)
  4. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Larotrectinib
  • Oral solution 20mg per 1ml

Notes

  1. NICE TA630: Larotrectinib (Vitrakvi) is recommended for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours, (May 2020), in adults and children if:
    1. the disease is locally advanced or metastatic or surgery could cause severe health problems and
    2. they have no satisfactory treatment options
Lorlatinib
  • Tablets 25mg, 100mg

Notes

  1. NICE TA628: Lorlatinib (Lorviqua) is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults (May 2020), whose disease has progressed after:
    1. alectinib or ceritinib as the first ALK tyrosine kinase inhibitor or
    2. crizotinib and at least 1 other ALK tyrosine kinase inhibitor
Midostaurin
  • Capsules 25mg

Notes

  1. NICE TA523: Midostaurin (Rydapt) is recommended, within its marketing authorisation, as an option in adults for treating newly diagnosed acute FLT3-mutation-positive myeloid leukaemia with standard daunorubicin and cytarabine as induction therapy, with high-dose cytarabine as consolidation therapy, and alone after complete response as maintenance therapy. It is recommended only if the company provides midostaurin with the discount agreed in the patient access scheme (Jun 2018)
  2. NICE TA728: Midostaurin (Rydapt) monotherapy is recommended, within its marketing authorisation, as an option for treating aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm, or mast cell leukaemia in adults. It is recommended only if the company provides midostaurin according to the commercial arrangement (September 2021)
Nilotinib
  • Capsules 150mg, 200mg

Notes

  1. NICE TA251: Dasatinib (not recommended), nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia (Apr 2012)
  2. NICE TA426: Dasatinib, nilotinib and imatinib recommended for untreated chronic myeloid leukaemia (Dec 2016)
  3. NICE TA425: Dasatinib, nilotinib and high-dose imatinib recommended for treating imatinib-resistant or intolerant chronic myeloid leukaemia (Dec 2016)
Pazopanib
  • Tablets 200mg, 400mg

Notes

  1. NICE TA215: Pazopanib is recommended for the first line treatment of metastatic renal cell carcinoma (Feb 2011)
  2. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection inpatients with risk factors (see Drug Safety Update) for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Pemigatinib
  • Tablets 4.5mg, 9mg, 13.5mg

Notes

  1. NICE TA722: Pemigatinib (Pemaryze) is recommended, within its marketing authorisation, as an option for treating locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after systemic therapy in adults (Aug 2021). It is recommended only if the company provides pemigatinib according to the commercial arrangement
Ponatinib
  • Tablets 15mg, 30mg, 45mg

Notes

  1. NICE TA451: Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia (Jun 2017)
  2. MHRA Drug Safety Update (Oct 2018): Ponatinib (Iclusig): reports of posterior reversible encephalopathy syndrome
  3. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Regorafenib
  • Tablets 40mg

Notes

  1. NICE TA488: Regorafenib (Stivarga) is recommended as an option 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, only when the criteria of the NICE TA are met (Nov 2017)
  2. NICE TA555: Regorafenib (Stivarga) is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib, only when the criteria of the NICE TA are met (Jan 2019)
  3. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Ruxolitinib
  • Tablets 5mg, 10mg, 15mg, 20mg

Notes

  1. NICE TA386: Ruxolitinib is recommended for treating disease-related splenomegaly or symptoms in adults with myelofibrosis (Mar 2016)
  2. Ruxolitinib has also been approved for use in certain conditions where all the criteria set out by the Cancer Drugs Fund are met.
Sorafenib
  • Tablets 200mg

Notes

  1. NICE TA178: Bevacizumab (Avastin), sorafenib (Nexavar), and temsirolimus (Torisel) are not recommended as first-line treatment options for people with advanced and/or metastatic renal cell carcinoma. Sorafenib (Nexavar) and sunitinib (Sutent) are not recommended as second-line treatment options for people with advanced and/or metastatic renal cell carcinoma (Aug 2009)
  2. NICE TA474: Sorafenib (Nexavar) is recommended as an option for treating advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment (Sept 2017)
  3. NICE TA535: Lenvatinib (Lenvima) and sorafenib (Nexavar) are recommended as options for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only when the criteria of the NICE TA are met (Aug 2018)
  4. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Sunitinib
  • Capsules 12.5mg, 25mg, 50mg

Notes

  1. NICE TA169: Sunitinib, recommended for first-line treatment of advanced and/or metastatic renal cell carcinoma (Mar 2009)
  2. NICE TA179: Sunitinib recommended for the treatment of gastrointestinal stromal tumours (Sept 2009)
  3. NICE TA449: Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease (Jun 2017)
  4. Sunitinib is not routinely commissioned for other indications. It has been approved for use in certain conditions where all the criteria set out by the Cancer Drugs Fund are met.
  5. NICE TA178: Renal cell carcinoma- Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma (not recommended) (Aug 2009)
  6. MHRA Drug Safety Update (Jan 2011). Treatment with bevacizumab or sunitinib may be a risk factor for the development of osteonecrosis of the jaw. Patients treated who have previously received, or are treated concurrently with bisphosphonates may be particularly at risk. Dental examination and appropriate preventative dentistry should be considered before treatment with bevacizumab or sunitinib. Invasive dental procedures should be avoided, if possible, in patients treated with bevacizumab or sunitinib who have previously received, or who are receiving, I/V bisphosphonates.
  7. MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    1. Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection inpatients with risk factors (see Drug Safety Update for a list of risk factors)
    2. In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    3. Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Tivozanib
  • Capsules 1.34mg

Notes

  1. NICE TA512: Tivozanib is recommended as an option for treating advanced renal cell carcinoma in adults (Mar 2018)
Trametinib dimethyl sulfoxide
  • Tablets 2mg

Notes

  1. NICE TA396: Trametinib (Mekinst) in combination with Dabrafenib (Trafinlar) is recommended as an option for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation (Jun 2016)
  2. NICE TA544: Dabrafenib (Trafinlar) with Trametinib (Mekinst) is recommended as an option for the adjuvant treatment of resected stage III, BRAF V600 mutation-positive melanoma in adults (Oct 2018)
Vandetanib
  • NICE TA550: Vandetanib (Caprelsa) is not recommended for treating aggressive and symptomatic medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease (Dec 2018)
  • MHRA Drug Safety Update (Jul 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
    • Before initiating a systemic VEGF pathway inhibitor, carefully consider the risk of aneurysm and artery dissection in patients with risk factors (see Drug Safety Update for a list of risk factors)
    • In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as smoking and hypertension
    • Monitor patients for and treat hypertension in accordance with recommendations in the SPC (click here)
Vemurafenib
  • Tablets 240mg

Notes

  1. NICE TA269: Vemurafenib recommended for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma (Dec 2012)

Taxanes

Cabazitaxel
  • Infusion 40mg/ml

Notes

  1. NICE TA391: Cabazitaxel is recommended for hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. (May 2016 updated Aug 2016)
Docetaxel
  • Solution for infusion 10mg/ml, 20mg/ml

Notes

  1. NICE TA101: Docetaxel for the treatment of hormone refractory prostate cancer (Jun 2006)
  2. NICE TA109: Docetaxel for the adjuvant treatment of early node-positive breast cancer (Sept 2006)
  3. NICE TA509: Pertuzumab, in combination with trastuzumab and docetaxel, is recommended for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti‑HER2 therapy or chemotherapy for their metastatic disease (Mar 2018)
Paclitaxel
  • Powder for suspension for infusion 100mg
  • Concentrate for solution for infusion 6mg/ml

Notes

  1. NICE TA55: Paclitaxel is recommended, in combination with a platinum-based compound or platinum-based therapy alone, for first-line chemotherapy (usually following surgery) in the treatment of ovarian cancer (Jan 2003)
  2. NICE TA284 : Bevacizumab (Avastin) in combination with paclitaxel and carboplatin is not recommended for first-line treatment of advanced ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] stages IIIB, IIIC and IV epithelial ovarian, fallopian tube or primary peritoneal cancer) (May 2013)
  3. NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride (Caelyx), paclitaxel, trabectedin (Yondelis) and gemcitabine for treating recurrent ovarian cancer (Apr 2016):
    1. Paclitaxel in combination with platinum or as monotherapy is recommended as an option for treating recurrent ovarian cancer
  4. NICE TA476: Paclitaxel as albumin-bound nanoparticles (nab paclitaxel; Abraxane) with gemcitabine is recommended as an option for untreated metastatic adenocarcinoma of the pancreas in adults, only if:
    1. other combination chemotherapies are unsuitable and they would otherwise have gemcitabine monotherapy (Sept 2017)
  5. MHRA Drug Safety Update (Dec 2014): Abraxane (paclitaxel, formulated as albumin-bound nanoparticles): potential presence of strands in intravenous infusion bag

Topoisomerase I inhibitors

Irinotecan hydrochloride
  • Solution for infusion 20mg in 1ml

Notes

  1. NICE TA307: Aflibercept (Zaltrap) in combination with irinotecan and fluorouracil-based therapy is not recommended for treating metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regime (Mar 2014)
Pegylated-liposomal Irinotecan hydrochloride
  • Onivyde® pegylated-liposomal concentrate for solution for infusion 4.3mg in 1ml

Notes

  1. NICE TA440: Pegylated liposomal irinotecan (Onivyde), in combination with 5‑fluorouracil and leucovorin, is not recommended for treating metastatic adenocarcinoma of the pancreas in adults whose disease has progressed after gemcitabine-based therapy (Apr 2017)
  2. MHRA Drug Safety Update (Mar 2019): Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events
  3. MHRA Drug Safety Update (Jul 2020): Liposomal and lipid-complex formulations: name change to reduce medication errors
Topotecan
  • Capsules 250 micrograms, 1mg
  • Powder for solution for infusion 1mg vial, 4mg vial
  • Concentrate solution for infusion 1mg/ml

Notes

  1. NICE TA183: Topotecan in combination with cisplatin is recommended as a option for women with recurrent or stage IVB cervical cancer only if they have not previously received cisplatin (Oct 2009)
  2. NICE TA184: Topetecan is recommended as an option only for people with relapsed small-cell lung cancer, only when the criteria of the NICE TA are met (Nov 2009)
  3. NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride (Caelyx), paclitaxel, trabectedin (Yondelis) and gemcitabine for treating recurrent ovarian cancer (Apr 2016):
    1. Topotecan is not recommended for treating the first recurrence of platinum‑sensitive ovarian cancer
    2. Topotecan is not recommended for treating recurrent platinum‑resistant or platinum‑refractory ovarian cancer
Trabectedin
  • Powder for solution for infusion vials 250microgram, 1mg

Notes

  1. NICE TA185: Trabectedin (Yondelis) is recommended as a treatment option for people with advanced soft tissue sarcoma (Feb 2010), if:
    1. treatment with anthracyclines and ifosfamide has failed or
    2. they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide
  2. NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride (Caelyx), paclitaxel, trabectedin (Yondelis) and gemcitabine for treating recurrent ovarian cancer (Apr 2016):
    1. Trabectedin (Yondelis) in combination with PLDH is not recommended for treating the first recurrence of platinum sensitive ovarian cancer
Trastuzumab
  • Solution for injection vials 120mg in 1ml
  • Powder for concentrate for solution for infusion vials 150mg

Notes

  1. Prescribe by brand. A biosimilar medicine is a biological medicine that is highly similar and clinically equivalent (in terms of quality, safety, and efficacy) to an existing biological medicine however they cannot be considered generic equivalents of the originator biological medicine. Because they are not identical, biological medicines must be prescribed by brand. The decision which brand to prescribe rests with the responsible clinician in consultation with the patient. Automatic substitution of brands at the point of dispensing is not appropriate for biological medicines.
  2. NICE TA recommendations also apply to trastuzumab biosimilar products that have a marketing authorisation allowing the use of the biosimilar for the same indications
  3. NICE TA34: Guidance on the use of trastuzumab for the treatment of advanced breast cancer (Mar 2002):
    1. Trastuzumab in combination with paclitaxel is recommended as an option for people with tumours expressing human epidermal growth factor receptor 2 (HER2) scored at levels of 3+ who have not received chemotherapy for metastatic breast cancer and in whom anthracycline treatment is inappropriate
    2. Trastuzumab monotherapy is recommended as an option for people with tumours expressing HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for metastatic breast cancer. Refer to NICE TA for detailed requirements of prior chemotherapy regimens
  4. NICE TA208: Trastuzumab, in combination with cisplatin and capecitabine or 5-fluorouracil, is recommended as an option for the treatment of people with human epidermal growth factor receptor 2 (HER2)-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction (Nov 2010) who:
    1. have not received prior treatment for their metastatic disease and
    2. have tumours expressing high levels of HER2 as defined by a positive immunohistochemistry score of 3 (IHC3 positive)
  5. NICE TA257: Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone-receptor-positive breast cancer that over expresses HER2 (Jun 2012):
    1. Trastuzumab in combination with an aromatase inhibitor is not recommended for first-line treatment in postmenopausal women with metastatic hormone-receptor-positive breast cancer that overexpresses HER2
  6. NICE TA509: Pertuzumab in combination with trastuzumab and docetaxel, is recommended for treating HER2-positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti HER2 therapy or chemotherapy for their metastatic disease (Mar 2018)
Trastuzumab deruxtecan
  • Powder for concentrate for solution for infusion vials 100mg

Notes

  1. NICE TA704: Trastuzumab deruxtecan (Enhertu) is recommended for use as an option for treating HER2‑positive unresectable or metastatic breast cancer in adults after 2 or more anti‑HER2 therapies (May 2021)
    1. It is recommended only if the conditions in the managed access agreement are followed
Trastuzumab emtansine
  • Powder for solution for infusion vials 100mg, 160mg

Notes

  1. NICE TA458: Trastuzumab emtansine (Kadcyla) is recommended as an option for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer in adults who previously received trastuzumab and a taxane, separately or in combination (Jul 2017)
  2. NICE TA632: Trastuzumab emtansine (Kadcyla) is recommended, within its marketing authorisation, as an option for the adjuvant treatment of 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 (Jun 2020

 

Home > Formulary > Chapters > 8. Immunomodulatory treatments and malignant disease > 8.1 Cytotoxic drugs > 8.1.5 Antineoplastic drugs > 8.1.5 Other antineoplastic drugs

 

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