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.
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Phase I/II data for Glaxo’s BRAF/MEK combination of dabrafenib and trametinib, both pending FDA approval as single agents, suggest compelling efficacy. The combination may see off-label use if the drugs are approved as monotherapies, though payment could be a big hurdle.
GSK’s Oncology Expansion Heavily Dependent On Dabrafenib, Trametinib
GlaxoSmithKline announced NDA filings for BRAF inhibitor dabrafenib and MEK inhibitor trametinib in metastatic melanoma on Aug. 3. The two compounds represent one-quarter of the company’s novel oncology agents in clinical development, according to the most recent pipeline update.
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