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

Editors Pick
Dairy giant Saputo Inc. is voluntarily recalling certain Gouda cheese products in the U.S. due to potential listeria contamination. Saputo said one of its suppliers, Deutsch Kase Haus, LLC of Middlebury, Indiana, notified the company that some specialty Gouda cheese products that it supplied to Saputo's Green Bay, Wisconsin facility may have been contaminated with Listeria monocytogenes. Amazon is exploring the possibility of using parachutes to drop drone-delivered packages. The e-commerce giant has been granted a patent titled, "Maneuvering a package following in-flight release from an unmanned aerial vehicle". U.S. food maker Kraft Heinz Co. (KHC) Friday confirmed that it has made a comprehensive proposal to Anglo-Dutch consumer goods company Unilever Plc or Unilever NV. The cash and stock offer values $143 billion. Further, Kraft Heinz noted that Unilever has declined the proposal, however it go ahead...
comments powered by Disqus
Follow RTT