Merck & Co., Inc. (MRK) Announces FDA Acceptance For Review Of MK-3475 Biologics License Application For Advanced Melanoma
5/6/2014 10:22:52 AM
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. The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA’s Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators.
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