In June 2018, it was approved by the FDA in combination with binimetinib for the treatment of people with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.

[6][7] Encorafenib is indicated in combination with binimetinib, for the treatment of people with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test;[2] in combination with cetuximab, for the treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy;[2] in combination with binimetinib, for the treatment of adults with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

[2] In December 2024, the FDA granted accelerated approval to encorafenib with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for people with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

[4] Approval of encorafenib in the United States was based on a randomized, active-controlled, open-label, multicenter trial (COLUMBUS; NCT01909453) in 577 participants with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

[6] The major efficacy measure was progression-free survival (PFS) using RECIST 1.1 response criteria and assessed by blinded independent central review.