Animedix

Padcev + Keytruda (perioperative) PDUFA Date (Astellas / Pfizer / Merck)

FDA PDUFA decision date for Padcev + Keytruda (perioperative) is April 7, 2026. Developed by Astellas / Pfizer / Merck. Indication: Cisplatin-ineligible muscle-invasive bladder cancer (perioperative). Current status: Verifying.

Indication

Cisplatin-ineligible muscle-invasive bladder cancer (perioperative)

Regulatory details

  • Company: Astellas / Pfizer / Merck
  • Therapeutic area: Oncology / Urology
  • Application type: sBLA
  • Review type: Priority
  • PDUFA date: 2026-04-07
  • Outcome: Pending