muscle invasive bladder cancer
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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.