×
ADVERTISEMENT

JUNE 29, 2018

FDA Approves Encorafenib and Binimetinib Combo for Melanoma With BRAF Mutations

By SPC News Staff

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.

The combination approval was based on the randomized, active-controlled, open-label, multicenter trial phase 3 COLUMBUS trial in 577 patients with BRAF V600E or V600K mutation-positive unresectable or