Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC081785

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel