Encorafenib in combination with cetuximab [ENC2]

For previously treated BRAF V600E mutation positive metastatic or locally advanced and inoperable colorectal cancer where the following criteria have been met:

1. This application is being made by and the first cycle of systemic anti-cancer therapy with encorafenib in combination with cetuximab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a histologically proven diagnosis of colorectal adenocarcinoma.
3. This patient’s colorectal cancer has been shown to be of RAS wild type.
4. This patient’s colorectal cancer has been shown to contain a BRAF V600E mutation.
5. The patient has failed one or two prior regimens for either metastatic or locally advanced and inoperable disease. Note: if the patient progressed through adjuvant chemotherapy or within 6 months of completing adjuvant chemotherapy, the patient can be classed as having received one line of treatment for metastatic disease. Please note below whether the patient has been previously treated with one or two prior regimens for advanced/metastatic disease:

• One prior regimen
• Two prior regimens

6. The has not received prior treatment with any BRAF inhibitor or MEK inhibitor unless this patient was treated with neoadjuvant encorafenib plus cetuximab prior to surgery for locally advanced but operable colon cancer within the FOxTROT 4 clinical trial (ISRCTN83842641). Please mark below which of these 2 clinical scenarios applies to this patient:

• No prior treatment with any BRAF or MEK inhibitor
• Treated with neoadjuvant encorafenib plus cetuximab prior to surgery for locally advanced but operable colon cancer within the FOxTROT 4 clinical trial

7. The patient has not received prior treatment with cetuximab or panitumumab or any other EGFR inhibitors unless this patient was treated with neoadjuvant encorafenib plus cetuximab prior to surgery for locally advanced but operable colon cancer within the FOxTROT 4 clinical trial (ISRCTN83842641). Please mark below which of these 2 clinical scenarios applies to this patient:

• No prior treatment with cetuximab or panitumumab or any other EGFR inhibitors
• Treated with neoadjuvant encorafenib plus cetuximab prior to surgery for locally advanced but operable colon cancer within the FOxTROT 4 clinical trial

8. The patient will be treated with encorafenib at an initial continuous dose of 300mg daily as part of a 28-day cycle.
9. The patient will be treated with cetuximab at a dose of 500mg/m2 every two weeks as part of a 28-day cycle.
10. The patient has an ECOG performance status (PS) of 0 or 1.
11. The patient has no active brain metastases or leptomeningeal metastases.
12. Encorafenib with cetuximab is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment, whichever is the sooner.
13. A formal medical review as to how the combination of encorafenib plus cetuximab is being tolerated and whether treatment with the combination of encorafenib plus cetuximab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
14. Where a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break approval form to restart treatment.
15. Encorafenib and cetuximab will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 06 April 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA668 (06 January 2021)

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.