logo
Share SHARE
FONT-SIZE Plus   Neg

GSK Submits Supplemental NDAs To FDA For Dabrafenib/trametinib Combination

U.K.-based drug maker GlaxoSmithKline plc (GSK, 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Netflix offers a bunch of popular movies, Netflix originals, new TV shows, and documentaries in the month of December 2016, including the second season of the hit sitcom 'Fuller House' and 2016 blockbuster 'Captain America: Civil War', as all are getting ready for the holidays. SpaceX, the space transport company of Tech entrepreneur Elon Musk, is likely to launch its first Falcon 9 rocket since September's launchpad explosion on December 16. SpaceX's satellite launch customer Iridium Communications Inc. announced Thursday that its next-generation global satellite constellation, Iridium NEXT, will be launched on SpaceX's Falcon 9 rocket. Bank holding company Wells Fargo & Co., amid struggles to re-establish itself after the fake-account scandal, on Thursday said it has separated the roles of the Chairman and Chief Executive Officer formally, by amending the company's By-Laws. The amendment is also for the Chairman and Vice Chairman of the Board to be independent directors. The amendments were effective immediately.
comments powered by Disqus
Follow RTT