Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

GSK Submits Supplemental NDAs To FDA For Dabrafenib/trametinib Combination

RELATED NEWS
Trade GSK now with 

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.

Click here to receive FREE breaking news email alerts for GlaxoSmithKline PLC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
A number of major retailers will be open on Thanksgiving for early Black Friday shopping events. Kohl's department stores will kick off Black Friday sales two hours earlier this year, at 6 p.m. Thanksgiving Day, while Macy's, Bon-Ton and Best Buy will open at the same time. J.C. Penney and Sears... Twitter Inc. has replaced its head of product Daniel Graf just six months after luring him over from Google, according to multiple reports. Graf, previously known for his work leading Google Maps, will retain his vice president of product title and work on Twitter's geolocation features, the Wall... LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that its third quarter loss widened slightly from last year, as higher costs and expenses more than offset a 45% increase in revenue. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.