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GSK Submits Supplemental NDAs To FDA For Dabrafenib/trametinib Combination

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7/9/2013 2:33 AM ET

U.K.-based drug maker GlaxoSmithKline plc (GSK: Quote, GSK.L) Tuesday announced submission of supplemental New Drug Applications or NDAs to the U.S. Food and Drug Administration or FDA for use of a BRAF inhibitor, dabrafenib, in combination with a MEK inhibitor trametinib. These applications are based from a randomised Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600E and V600K mutation positive metastatic melanoma.

The use of these drugs in combination is investigational, the company said, and is not approved anywhere else. European review of the MAA submission for trametinib, both as monotherapy and in combination with dabrafenib, is ongoing. CHMP has reverted from the accelerated assessment review process to standard timelines to allow sufficient time for review of the submission.

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by RTT Staff Writer

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