Priority Review for Keytruda in RCC, head and neck cancer

FDA accepted and granted Priority Review to two sBLAs for anti-PD-1 mAb Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK).

The agency assigned a June 10 PDUFA date to an sBLA for Keytruda as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy to treat squamous cell carcinoma of the head and neck (SCCHN) in a first-line setting...