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
Taco Bell, a division of Yum! Brands Inc, is planning to test delivery of food items on college campuses, the Street reported. The move comes at a time the fast food chain seeks to leverage demand for its popular breakfast and dinner items. In an unusual incident, an Airbus operated by Singapore Airlines temporarily lost power on both its Rolls Royce engines during a flight and plunged almost 13,000 feet or 3.96 kilometers. However, pilots managed to save the Airbus through standard operational procedures and it continued on its routine path. Hormel Foods has agreed to buy organic meat products maker Applegate Farms LLC for about $775 million, as consumers increasingly use natural and organic foods in their diet.
comments powered by Disqus
Follow RTT