Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma

Dateline City: WHITEHOUSE STATION, N.J. Expects to Complete Application in First Half of 2014 WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today it has started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. Language: English Contact: MerckMedia:Ian McConnell, 908-423-3046Claire Mulhearn, 908-423-7425orInvestors:Carol Ferguson, 908-500-1101Justin Holko, 908-423-5088 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Source: Merck.com - Research and Development News - Category: Pharmaceuticals Tags: Oncology Newsroom Research and Development News Corporate News Latest News Source Type: news