durvalumab (Imfinzi) plus chemotherapy: FDA status

Approved Approved Jul 3, 2025. Indication: Perioperative (neoadjuvant and adjuvant) treatment of muscle invasive bladder cancer. Company: AstraZeneca.

Regulatory history

Jul 3, 2025: Approved. FDA approved durvalumab for perioperative immunotherapy in muscle invasive bladder cancer. Wiley & Sons
Apr 7, 2025: Approved. FDA approved durvalumab for muscle invasive bladder cancer. Oncodaily
Mar 28, 2025: Approved. FDA approved durvalumab plus chemotherapy for muscle invasive bladder cancer. Urology Times
Dec 6, 2024: Priority review. FDA granted priority review to durvalumab plus chemotherapy in bladder cancer. CancerNetwork
Dec 6, 2024: FDA accepted for review. FDA granted priority review to sBLA for durvalumab in muscle invasive bladder cancer per AstraZeneca news release. urologytimes.com

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