Encorafenib (in combination with binimetinib) [ENC1]
The treatment of unresectable stage III stage IV BRAF V600 mutation positive malignant melanoma where the following criteria are met:
- This application is made by and the first cycle of systemic anti-cancer therapy with encorafenib in combination with binimetinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy
- This patient has a confirmed histological diagnosis of malignant melanoma.
- This patient’s cancer has been shown to contain a BRAF V600 mutation.
- The patient has unresectable stage III or stage IV disease that has been staged according to the AJCC 8th edition
- The patient is treatment naïve to BRAF V600 and MEK inhibitors for malignant melanoma unless either the patient has previously received adjuvant dabrafenib and trametinib and did not progress during such therapy or has received a sufficient trial of dabrafenib plus trametinib for advanced disease and this has had to be stopped solely as a consequence of persistent dose-limiting toxicity and in the documented absence of disease progression. or Note: sequential treatment is not commissioned with dabrafenib plus trametinib and then on disease progression with encorafenib plus binimetinib.
- The patient has sufficient ECOG performance status to tolerate treatment with the combination of encorafenib plus binimetinib
- Treatment with encorafenib in combination with binimetinib will be continued until loss of clinical benefit or unacceptable toxicity or withdrawal of patient consent unless the patient is enrolled in the DyNAMIc clinical trial (trial reference CTA 21266/0255/001-0001) in which case an intermittent adaptive dosing schedule as guided by circulating tumour DNA levels can be used as per the trial protocol.
- A formal medical review as to whether treatment with encorafenib in combination with binimetinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment
- Where a treatment break of more than 6 weeks beyond the expected cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19. Note: patients in the DyNAMIc clinical trial (trial reference CTA 21266/0255/001-0001) who draw the adaptive intermittent treatment arm do not need to apply for approval to restart after treatment breaks that are a planned part of the trial schedule.
- Encorafenib in combination with binimetinib is to be otherwise used as set out in their respective Summaries of Product Characteristics
NHS funded From: 28 May 2019
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.