Merck's PD-1 Antibody for Metastatic Melanoma to Get Priority Review

Food and Drug Administration

Merck , known as MSD outside the United States and Canada, today announced that the U.S. (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.

Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014.

Read the report here: http://on.mktw.net/1opOBV9

Source: MarketWatch