GlaxoSmithKline announced that the FDA has granted accelerated approval for the combination use of Mekinist (trametinib) and Tafinlar (dabrafenib) for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

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The approval was based on the results of a multicenter, open-label, randomized, active-controlled, dose-ranging Phase I/II trial, which compared combination Mekinist and Tafinlar to Tafinlar monotherapy. The primary endpoint was investigator-assessed overall response rate (ORR). 

The ORR was 76% (95% CI; 62, 87) with combination therapy compared to 54% (95% CI; 40, 67) with Tafinlar monotherapy. The median duration of response was 10.5 months (95% CI; 7, 15) with combination therapy compared to 5.6 months (95% CI; 5, 7)  with monotherapy.

The accelerated approval is contingent on the results of the ongoing Phase III Combi-D trial that is evaluating the clinical benefit of combination therapy.

Mekinist is a mitogen-activated extracellular kinase (MEK) inhibitor that blocks the activation of the protein-kinase B-raf (BRAF) pathway, thereby causing decreased cellular proliferation, cell cycle arrest, and increased apoptosis. 

Tafinlar is a selective BRAF inhibitor that blocks tumor cell growth through inhibition of some mutated forms of BRAF, including the BRAFV600 mutation. 

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