The FDA issued an alert about decreased survival associated with the use of pembrolizumab (Keytruda, Merck) or atezolizumab (Tecentriq, Genentech) as monotherapy in previously untreated patients with metastatic urothelial cancer (UC) and low programmed death ligand-1 (PD-L1) expression.
The alert came in response to early data monitoring committee reviews of two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130) indicating that patients with low PD-L1 expression in the monotherapy arms of