Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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.

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
Global consumer confidence increased in the second quarter to reach the highest levels since the first quarter in 2007 as job optimism improved, results of a survey by Nielsen showed Tuesday. The Nielsen Global Consumer Confidence Index rose a point from the previous quarter to 97 in the second quarter.... Texas Instruments Inc., the world's largest maker of analog chips, said Monday after the markets closed that its second quarter profit rose 3% from last year, as revenue increased 8%. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave an upbeat outlook for the third quarter. After coming under pressure in early trading on Monday, stocks regained some ground over the course of the trading session but still closed modestly lower. The pullback on the day partly offset the strength that was seen last week.
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.