Merck Gets FDA Priority Review, Bladder Cancer

Merck announced FDA granted priority review for KEYTRUDA and KEYTRUDA QLEX combined with Padcev for muscle‑invasive bladder cancer.
The FDA set a target action date of August 17, 2026 for the two supplemental Biologics License Applications.
Phase 3 KEYNOTE‑B15 trial data supporting the applications showed improved survival outcomes for patients eligible for cisplatin‑based chemotherapy.