FDA Grants Pembrolizumab/Axitinib Combo Priority Review for Frontline RCC

February 15, 2019 – The FDA has granted a priority review designation to a supplemental biologics license application (sBLA) for the combination of pembrolizumab and axitinib as a frontline treatment for patients with advanced renal cell carcinoma (RCC). The application is primarily based on data from the phase III KEYNOTE-426 study, which demonstrated that the frontline combination significantly improved progression-free and overall survival (OS) compared with … (leggi tutto)