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: 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
H&R Block, Inc., the largest U.S. tax preparer, said Wednesday after the markets closed that its third quarter loss narrowed sharply from last year, as revenue surged due to an earlier opening of the Internal Revenue Service's e-file system this tax season. The company's quarterly loss per share also smaller than analysts estimated, but its quarterly revenue fell short of analysts' forecast. Microsoft co-founder Paul Allen's maritime plunge took an exciting yet somber turn, after he found the wreck of a once-feared World War II Japanese battleship that met its doom by enemy torpedoes decades ago near the Philippines. A new study reveals that more large companies in the U.S. are run by men with the names John, Robert, William or James than the total number of women CEOs. For each women CEO of S&P 1500 companies there are four men CEOs named John, Robert, William or James, according to a study conducted by the New...
comments powered by Disqus
RELATED NEWS
Trade GSK now with 
Follow RTT