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Glaxosmithkline Plc gains accelerated FDA approval for combination use of Mekinist (trametinib) and Tafinlar (dabrafenib)


Wednesday, 8 Jan 2014 10:24pm EST 

Glaxosmithkline Plc:Says 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 or metastatic melanoma with BRAF V600E or V600K mutations.Says these mutations must be detected by an FDA-approved test.Sasy Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.Says approval of the combination is based on the demonstration of response rate and median duration of response in a Phase I/II study.Says improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar.Says the combination was approved through the FDA's Accelerated Approval programme and reviewed under a Priority Review designation.Says 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.