EMA and FDA prune the checkpoint inhibitor treatment landscape

The European Medicines Agency (EMA) and FDA have recently restricted the indications for first-line pembrolizumab and atezolizumab to patients with programmed cell death 1 ligand 1 (PD-L1)-high advanced urothelial carcinoma, a decision made following interim analyses from the ongoing Keynote-361 and IMvigor130 phase III trials. Questions remain on the magnitude of inferior survival and standardized implementation of PD-L1 testing.