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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review
2015-08-18 14:00:00| Merck.com - Product News
Dateline City: KENILWORTH, N.J. Merck Provides Additional Update: FDA Extends Action Date for Additional sBLA in Ipilimumab-Refractory Advanced Melanoma KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orInvestors:Justin Holko, 908-740-1879An Phan, 908-255-6325 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Category:Biotechnology and Pharmaceuticals