U.S. FDA Grants Priority Review to sBLA for PADCEVtm + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

The US FDA has accepted for Priority Review a supplemental Biologics License Application for PADCEV in combination with Keytruda as a perioperative treatment for muscle-invasive bladder cancer. The application is based on data from the Phase 3 EV-304 trial, which showed a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduced risk of death compared to standard of care neoadjuvant chemotherapy. The FDA has set a target action date of August 17, 2026. If approved, this regimen would be the first and only perioperative treatment for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility. The combination demonstrated a pathological complete response rate of 55.8% compared with 32.5% in the chemotherapy arm. The safety profile was consistent with prior experience with the combination.