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Merck & Co., Inc. (MRK) Initiates Rolling Submission Of U.S. Biologics License Application For MK-3475, An Investigational Anti-PD-1 Immunotherapy, In Patients With Advanced Melanoma


1/13/2014 11:13:28 AM

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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. The company expects to complete the application in the first half of 2014.

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