Mekinist/Tafinlar Combo Approved for Melanoma

January 9, 2014 4:49 PM

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Mekinist/Tafinlar Combo Approved for Melanoma

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.

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).

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