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Merck files BLA for anti-PD-1 immunotherapy

By Michael Fitzhugh
Staff Writer

Wednesday, May 7, 2014

Merck & Co. Inc. on Tuesday completed filing its FDA biologics license application for MK-3475 (pembrolizumab), its high-profile programmed cell death 1 (PD-1) inhibitor. The company is seeking approval to treat melanoma patients unsuccessfully treated with Yervoy (ipilimumab, Bristol-Myers Squibb Co.), an indication for which the FDA has granted it both breakthrough designation and priority review status.

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