U.S. FDA grants Priority Review to sBLA for PADCEV + Keytruda as perioperative treatment for MIBC regardless of Cisplatin eligibility

CAR-T Digest - August 2020

Weekly Digest - April 2026

20 April 2026: U.S. FDA grants Priority Review to sBLA for PADCEV + Keytruda as perioperative treatment for MIBC regardless of Cisplatin eligibility

U.S. Food and Drug Administration has granted Priority Review to a supplemental BLA for the combination of PADCEV plus Keytruda as a perioperative treatment for muscle-invasive bladder cancer (MIBC), aiming to expand its use to patients regardless of cisplatin eligibility
The application is supported by the phase 3 EV-304 (KEYNOTE-B15) trial, where the combination demonstrated significant efficacy, including a 47% reduction in risk of recurrence/progression/death, a 35% reduction in mortality risk, and a notably higher pathological complete response rate (55.8% vs 32.5%) compared to chemotherapy
These findings support an expansion beyond its current use in cisplatin-ineligible patients, with the new filing aiming to extend the regimen to a broader MIBC population regardless of cisplatin eligibility
Mechanistically, PADCEV, a Nectin-4–directed ADC, combined with the PD-1 inhibitor Keytruda, represents a novel chemo-free perioperative approach, potentially transforming treatment by improving outcomes both before and after surgery
Overall, this Priority Review highlights the regimen’s potential to reduce recurrence risk and extend survival, reinforcing its role as a promising advancement in bladder cancer care, with ongoing discussions planned with global regulators for broader approvals