Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

Dateline City: BOSTON Priority Review Designation for MK-3475 BLA for Proposed Indication of Unresectable or Metastatic Melanoma in Patients Who Have Been Previously Treated with Ipilimumab Advancing New Phase 3 Studies with MK-3475 in Adjuvant Melanoma, Previously-Untreated Non-Small Cell Lung Cancer, Advanced Head & Neck and Bladder Cancers Data from Studies in Three Different Cancer Types to be presented at 2014 ASCO Annual Meeting Initiating Phase 1 Study with Investigational Anti-GITR Antibody (MK-4166) BOSTON--(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 Biologics License Application (BLA) for MK-3475, Merck’s investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. Language: English Contact: MerckMedia:Ian McConnell, 973-901-5722Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-423-4465Justin Holko, 908-423-5088 ...
Source: Merck.com - Corporate News - Category: Pharmaceuticals Tags: Oncology Newsroom Corporate News Latest News Source Type: news