GlaxoSmithKline plc announced that the U.S. Food and Drug Administration (FDA) has approved Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.
The approval of the combination is based on the demonstration of response rate and median duration of response in a Phase 1/2 study. Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The combination was approved through the FDA’s Accelerated Approval program and reviewed under a Priority Review designation. This accelerated approval is contingent on the results of the ongoing Phase 3 trial (referred to as MEK115306 or Combi-D), which is designed to evaluate the clinical benefit of the combination in this patient population.