The FDA approved the use of encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by the THxID BRAF Kit (bioMérieux), which was also approved. Encorafenib is not indicated for treatment of patients with wild-type BRAF melanoma.
The combination approval was based on the randomized, active-controlled, open-label, multicenter trial phase 3