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Merck & Co Inc announces FDA acceptance for review of MK-3475 biologics license application for advanced Melanoma


Tuesday, 6 May 2014 08:40am EDT 

Merck & Co Inc:Says U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Application (BLA) for MK-3475, Merck's investigational anti-PD-1 antibody.For treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab.FDA granted Priority Review designation with PDUFA date of Oct. 28, 2014, and MK-3475 BLA will be reviewed under FDA's Accelerated Approval program.FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, most dangerous type of skin cancer.If approved by FDA, MK-3475 has potential to be first anti-PD-1 antibody in new class of immune checkpoint modulators.Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014. 

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19 Dec 2014