FDA Grants Pembrolizumab Priority Review for HCC

July 11, 2018 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for pembrolizumab for previously treated patients with advanced hepatocellular carcinoma (HCC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor. The sBLA is based on findings from the phase II KEYNOTE-224 trial, in which single-agent pembrolizumab induced an overall response rate (ORR) of 17% (95% CI, 11-26) among 104 patients with … (leggi tutto)