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
Here is a quick summary of the earnings reported after the bell on Jul 27. 1.Del Taco Restaurants, Inc. (TACO, TACOW) Q2 Net income was $4.6 million compared to net loss of $0.1 million a year ago. Q2 Total revenue was $97.6 million, an increase of 7.0% compared to $91.2 million a year ago. *** 2.Plantronics,... Semiconductor packaging company Amkor Technology Inc. (AMKR), Monday reported a plunge in profit for the second quarter, as revenues declined and margins narrowed. The bottom line was also impacted by a debt extinguishment charge. Shares of the company fell about 14 percent in extended hours after... Hartford Financial reported a swing to profit for the second quarter, helped mainly by improved underwriting results in property and casualty business, and contribution from Talcott Resolution, while the prior year included a one-time loss from discontinued operations. Hartford's quarterly earnings easily topped Wall Street estimates...
comments powered by Disqus
Follow RTT