FDA approves Merck's Keytruda

FDA granted accelerated approval to Keytruda pembrolizumab ( MK-3475) from Merck & Co. Inc. (NYSE:MRK) to treat advanced melanoma in patients previously treated with Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY). Keytruda is the first programmed cell death 1 receptor ( PDCD1; PD-1; CD279) inhibitor approved in the U.S.

FDA approved the drug based on data from 173 patients with advanced melanoma in the ongoing Phase Ib KEYNOTE-001 trial, which showed that 24% of patients who received the recommended dose of 2 mg/kg every three weeks had tumor shrinkage. ...