Indications of Encorafenib

Unresectable or Metastatic Melanoma with Positive BRAF V600E or V600K Mutation

Encorafenib in combination with binimetinib is indicated for the treatment of patients with unresectable or metastatic melanoma whose BRAF V600E or V600K mutation has been confirmed by an FDA-approved test.

Metastatic Colorectal Cancer with Positive BRAF V600E Mutation

Encorafenib in combination with cetuximab and the mFOLFOX6 regimen is indicated for the treatment of patients with metastatic colorectal cancer whose BRAF V600E mutation has been confirmed by an FDA-approved test. This indication was granted accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Encorafenib in combination with cetuximab is indicated for the treatment of adult patients with metastatic colorectal cancer whose BRAF V600E mutation has been confirmed by an FDA-approved test and who have received prior treatment.

Metastatic Non-Small Cell Lung Cancer with Positive BRAF V600E Mutation

Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer whose BRAF V600E mutation has been confirmed by an FDA-approved test.

Usage Limitations

Encorafenib is not indicated for the treatment of patients with BRAF wild-type melanoma, BRAF wild-type colorectal cancer, or BRAF wild-type non-small cell lung cancer.

FDA，2025.03