FDA Grants Pembrolizumab Priority Review in Second-Line Bladder Cancer

February 3rd, 2017 – The FDA has granted a priority review to a supplemental Biologics License Application (sBLA) for pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial cancer who progress following platinum-containing chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor. The sBLA is based on data from the phase III KEYNOTE-045 study, in which single-agent pembrolizumab reduced the … (leggi tutto)