FDA Approves Drug Duo for BRAF-Positive Melanoma

Source: Cure, June 2018

The FDA has approved the combination of the BRAF inhibitor Braftovi (encorafenib) and the MEK inhibitor Mektovi (binimetinib) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.

The approval is based on the phase 3 COLUMBUS trial, in which at a median follow-up of 36.8 months, combining Braftovi at 450 mg daily and Mektovi at 45 mg twice daily (COMBO450) reduced the risk of death by 39 percent versus Zelboraf (vemurafenib) monotherapy. The median overall survival (OS) was 33.6 months versus 16.9 months, respectively.