U.S. FDA Grants Priority Review to PADCEV® + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
The FDA granted Priority Review to a supplemental Biologics License Application for perioperative PADCEV in combination with Keytruda, expanding the indication for muscle‑invasive bladder cancer patients regardless of cisplatin eligibility.
The FDA accepted a supplemental Biologics License Application for the combination of PADCEV, an anti‑Nectin‑4 antibody‑drug conjugate, with Keytruda, a PD‑1 inhibitor, as perioperative therapy for muscle‑invasive bladder cancer. Data from the Phase 3 EV‑304 trial showed a 47 % reduction in recurrence or progression and a 35 % reduction in mortality versus standard neoadjuvant chemotherapy, supporting the priority review status.
If approved, this perioperative regimen may become the first and only treatment option for muscle‑invasive bladder cancer patients irrespective of cisplatin eligibility, potentially lowering recurrence rates and improving overall survival after surgery.
Evidence level: Irányelv / elfogadott gyakorlat. Magas szintű klinikai elfogadottság.