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

PUBT·09/25/2026 06:04:58
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AstraZeneca Imfinzi-enfortumab vedotin combo wins FDA priority review for muscle-invasive bladder cancer
  • 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.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AstraZeneca plc published the original content used to generate this news brief on September 25, 2026, and is solely responsible for the information contained therein.