FDA Warns Against Single-Agent Checkpoint Inhibition for PD-L1-Low Untreated Urothelial Carcinoma

May 19, 2018 – The FDA has issued a drug safety notification warning against the use of frontline single-agent immune checkpoint inhibition for patients with PD-L1–low expressing platinum-eligible urothelial carcinoma, following a demonstration of lower overall survival with pembrolizumab and atezolizumab compared with platinum-based chemotherapy. The FDA warning was based on an assessment conducted by a data monitoring committee (DMC) for the phase III KEYNOTE-361 … (leggi tutto)