AstraZeneca Imfinzi-enfortumab vedotin combo wins FDA priority review for muscle-invasive bladder cancer

By Public Technologies
  • AstraZeneca won FDA Priority Review for Imfinzi with enfortumab vedotin in muscle-invasive bladder cancer patients ineligible for cisplatin.
  • Filing seeks perioperative use with neoadjuvant enfortumab vedotin before cystectomy; decision due in Q4 2026 under the PDUFA clock.
  • Application rests on Phase III VOLGA interim data showing significant gains in event-free survival, overall survival versus surgery with or without adjuvant therapy.


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