FDA Grants Pembrolizumab Priority Review for Frontline HNSCC

February 11, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for pembrolizumab alone or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The application is based on the data from the phase III KEYNOTE-048 trial, in which pembrolizumab alone led to a … (leggi tutto)