GlaxoSmithKline Deals One-Two Punch With BRAF/MEK Pair
This article was originally published in The Pink Sheet Daily
Executive Summary
GSK presented Phase III results for its BRAF inhibitor dabrafenib and its MEK inhibitor trametinib at the American Society of Clinical Oncology annual meeting June 4. But the real excitement is over the just-starting Phase III trial combining the two drugs.
You may also be interested in...
Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs
GlaxoSmithKline withdrew priority review requests for its high-profile melanoma drugs Mekinist and Tafinlar as extensive problems with both the quality of the NDA data and the statistical analysis software in the electronic submissions emerged. Statistical reviewers called out sponsor for inadequate response to problems, wasting time.
Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs
GlaxoSmithKline withdrew priority review requests for its high-profile melanoma drugs Mekinist and Tafinlar as extensive problems with both the quality of the NDA data and the statistical analysis software in the electronic submissions emerged. Statistical reviewers called out sponsor for inadequate response to problems, wasting time.
Tandem Approval Brings GSK’s Tafinlar And Mekinist To A Market Ready To Test Combinations
Glaxo’s BRAF inhibitor dabrafenib and MEK inhibitor trametinib were approved as single agents for advanced melanoma, but the real promise lies in combination therapy for better efficacy and safety. Labeling for trametinib notes it is not indicated in patients who have already received BRAF therapy.