FDA Grants Pembrolizumab Priority Review for Merkel Cell Carcinoma

September 4, 2018 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for pembrolizumab for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor. The sBLA is based on data from the phase II KEYNOTE-017 trial, which included 50 patients with metastatic or locally advanced MCC who … (leggi tutto)