Combination of Mekinist and Tafinlar for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, approved by FDA
The FDA ( Food and Drug Administration ) has approved Mekinist ( Trametinib ) for use in combination with Tafinlar ( Dabrafenib ) for the treatment of patients with unresectable melanoma or metastatic melanoma 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 I/II 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 programme and reviewed under a Priority Review designation.
This accelerated approval is contingent on the results of the ongoing phase III trial ( referred to as MEK115306 or Combi-D ), which is designed to evaluate the clinical benefit of the combination in this patient population. ( Xagena )
Source: GSK, 2014