FDA approves durvalumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
On November 13, 2026, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with enfortumab vedotin-ejfv as neoadjuvant treatment followed by single-agent durvalumab as adjuvant therapy after radical cystectomy for adult patients with muscle invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy. The approval was granted under priority review and six weeks ahead of the FDA goal date.
Primary source
FDA approval notification, November 13, 2026
FDA approves durvalumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer
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