Indications of Encorafenib

Encorafenib® and Binimetinib® are both kinase inhibitors, and their combination therapy is indicated for the treatment of patients with unresectable or metastatic melanoma harboring a BRAF V600E or V600K mutation, as confirmed by an FDA-approved test.

Encorafenib in combination with cetuximab and the mFOLFOX6 regimen is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation, as confirmed by an FDA-approved test. This indication is approved under accelerated approval based on overall 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 (mCRC) harboring a BRAF V600E mutation, as confirmed by an FDA-approved test, who have experienced disease progression following prior therapy.

Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring a BRAF V600E mutation, as confirmed by an FDA-approved test.

Use Restriction: 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