FDA Review Continues for Pembrolizumab in MSI-H Cancer

March 10, 2017 – A supplemental biologics license application (sBLA) for pembrolizumab for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer remains under review by the FDA, according to a statement from Merck, the manufacturer of the anti–PD-1 agent. Merck announced in November 2016 that pembrolizumab had received a priority review from the FDA for use in this setting, with a final decision expected under the Prescription … (leggi tutto)