AstraZeneca Imfinzi-enfortumab vedotin combo wins FDA priority review for muscle-invasive bladder cancer
AZN•The FDA granted priority review to AstraZeneca’s application for perioperative Imfinzi with enfortumab vedotin in cisplatin-ineligible muscle-invasive bladder cancer; a decision is due in the fourth quarter of 2026.
1. FDA review timeline
AstraZeneca said its application seeks perioperative use of Imfinzi with neoadjuvant enfortumab vedotin before cystectomy for patients with muscle-invasive bladder cancer who are ineligible for cisplatin. The filing is based on interim Phase III VOLGA data showing significant gains in event-free and overall survival versus surgery with or without adjuvant therapy.
