Home FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review
 

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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Mercks Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review

2015-06-01 22:34:00| Merck.com - Product News

Dateline City: KENILWORTH, N.J. KEYNOTE-001 Data Served as the Basis for U.S. FDA Filing and Breakthrough Therapy Designation in Advanced NSCLC Across Histologies KENILWORTH, 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 accepted for review the supplemental Biologics License Application (sBLA) for Mercks anti-PD-1 therapy, KEYTRUDA (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. Language: English Contact: MerckMedia:Pamela Eisele, 267-664-0282Claire Mulhearn, 908-200-1889orInvestors:Joseph Romanelli, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more

Tags: advanced review application license

Category:Biotechnology and Pharmaceuticals

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