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
Online retail giant Amazon.com Inc. (AMZN) is reportedly in talks to buy luxury online fashion retailer Net-a-Porter. The news of acquisition was first reported by Women's Wear Daily, which said the deal would be completed for about 2 billion euros, indicating the biggest acquisition yet by Amazon.... Tim Cook, the CEO of tech giant Apple Inc., in an interview said he intends to give away all his wealth to charity. Cook, in an interview to Fortune, said he plans to donate all his wealth to philanthropic projects after paying for his 10-year old nephew's college education. According to Fortune,... Is it a 'personal life crisis' that led the Germanwings' co-pilot Andreas Lubitz to deliberately lowering the plane carrying 149 people to French Alps mountain? Police is investigating to find evidences to prove this suggestion.
comments powered by Disqus
RELATED NEWS
Trade GSK now with 
Follow RTT