• FDA cleared PADCEV with Keytruda for neoadjuvant, adjuvant treatment of adult muscle-invasive bladder cancer, regardless of cisplatin eligibility.
• EV-304 data showed improved event-free survival versus gemcitabine-cisplatin, hazard ratio 0.53; 2-year event-free rate 79.4% versus 66.2%.
• Overall survival improved, hazard ratio 0.65; pathological complete response reached 55.8% versus 32.5% at surgery.
• Astellas co-develops PADCEV; approval establishes the first FDA-cleared platinum-free perioperative regimen for muscle-invasive bladder cancer.

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