FDA approves Pfizer PADCEV-Keytruda combo for bladder cancer treatment
PFE•Astellas co-develops PADCEV
PADCEV is co-developed with Astellas. The FDA decision expands Pfizer’s oncology portfolio and adds a new treatment option in the perioperative setting for muscle-invasive bladder cancer.
Trial data showed stronger survival and response outcomes
The approval was supported by EV-304 data. In the study, the combination improved event-free survival versus gemcitabine-cisplatin, with a hazard ratio of 0.53 and a 2-year event-free rate of 79.4% versus 66.2%. Overall survival also improved, with a hazard ratio of 0.65. Pathological complete response at surgery was 55.8% versus 32.5%.
FDA clears perioperative use in muscle-invasive bladder cancer
The FDA approved Pfizer’s PADCEV in combination with Keytruda for the neoadjuvant and adjuvant treatment of adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility. The approval makes it the first FDA-cleared platinum-free perioperative regimen for this cancer type.
