Posted by Michael Wonder on 27 Jun 2018
Array BioPharma announces FDA approval of Braftovi (encorafenib) in combination with Mektovi (binimetinib)
27 June 2018 - Approval based on Phase 3 COLUMBUS trial which demonstrated nearly 15 months median progression-free survival.
Array BioPharma today announced that the U.S. FDA has approved Braftovi capsules in combination with Mektovi tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.
Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma.
