FDA approves durvalumab and enfortumab for muscle invasive bladder cancer

The FDA approved durvalumab (Imfinzi) with enfortumab vedotin-ejfv as treatment before radical cystectomy, followed by durvalumab alone after surgery, for adults with muscle invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy. The FDA announced the approval on November 13, 2026.

Compared with radical cystectomy alone, the combination regimen showed statistically significant improvements in event-free survival (EFS) and overall survival (OS). Median EFS was not reached with the combination and was 12.1 months with surgery alone. Median OS was not reached in either group. The FDA listed increased AST, increased ALT, decreased hemoglobin, rash, increased creatinine and pruritus among the most common adverse reactions. The review was conducted under Project Orbis, with input from agencies in six countries.