Merck, Pfizer, Astellas Drug Combo Gets Speedy FDA Review in Bladder Cancer

Merck, Pfizer, and Astellas Pharma have received priority review from the FDA for their Keytruda/Padcev drug combination aimed at treating muscle-invasive bladder cancer. This designation, which shortens the review period, is granted to drugs that may significantly improve treatment for serious diseases. The FDA's target action date for the applications is August 17. If approved, this regimen would be the first perioperative treatment for muscle-invasive bladder cancer, regardless of cisplatin eligibility, potentially establishing a new standard of care.