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Merck Receives Accelerated Approval of KEYTRUDA (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy

2014-09-04 21:15:00| Merck.com - Corporate News

Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046orClaire Mulhearn, 908-423-7425orInvestor:Joseph Romanelli, 908-423-5185orJustin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: approval therapy receives accelerated

Category:Biotechnology and Pharmaceuticals

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