FDA Grants Nivolumab/Ipilimumab Priority Review for RCC

December 14, 2017 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for use of the combination of nivolumab and ipilimumab as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The sBLA is based on the phase III CheckMate-214 trial, in which frontline treatment with the combination of nivolumab and ipilimumab reduced the risk of death by 32% compared with sunitinib … (leggi tutto)