BioCentury
ARTICLE | Company News

Priority Review for Keytruda in bladder cancer

February 3, 2017 10:09 PM UTC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to two sBLAs for Keytruda pembrolizumab to treat locally advanced or metastatic urothelial cancer, each with a June 14 PDUFA date. One covers treatment with Keytruda in cisplatin-ineligible patients in the first-line setting, and the other in patients who progressed on or after chemotherapy.

On Thursday, Bristol-Myers Squibb Co. (NYSE:BMY) said FDA granted accelerated approval to rival anti-PD-1 mAb Opdivo nivolumab to treat urothelial cancer in a second-line setting. PD-L1 inhibitor Tecentriq atezolizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY), has accelerated approval for second-line bladder cancer (see BioCentury Extra, Feb. 2)...