FDA Approves Durvalumab Combination for Bladder Cancer

The Food and Drug Administration approved a new treatment path on November 13, 2026, for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy or who refused it. Durvalumab, sold as Imfinzi by AstraZeneca, is given with enfortumab vedotin-ejfv before surgery, and durvalumab continues on its own after the bladder is removed.

The approval covers the stretch of care around a radical cystectomy, the operation that removes the bladder. Enfortumab vedotin-ejfv is the antibody-drug conjugate sold as Padcev. Durvalumab is an immunotherapy. The combination is meant to shrink the cancer before surgery and lower the chance that it comes back after.

The evidence comes from VOLGA, a randomized, open-label trial that enrolled 695 patients who were candidates for cystectomy and couldn't take cisplatin or declined it. In the results reported at the planned interim analysis, 78.4 percent of patients on the combination were alive after two years, against 69.4 percent with surgery alone.

That gap matters because this cancer returns often. Thomas Powles, the trial's international coordinating investigator, has noted that the disease comes back in about half of patients despite bladder-removal surgery. A treatment that moves two-year survival by nine points gives those patients a real option where cisplatin, the standard backbone, isn't one.

The FDA ran the review under Project Orbis, its Oncology Center of Excellence program for reviewing cancer drugs alongside regulators in other countries. The agency worked with reviewers in Australia, Brazil, Canada, Israel, Singapore and the United Kingdom, and applications are also under review in the European Union and Japan.

The decision arrived six weeks ahead of the FDA's target action date, after the application received priority review. It's the second durvalumab approval in this disease this year in a broader sense: the agency approved a different durvalumab regimen, with pembrolizumab and enfortumab, for a wider group of bladder cancer patients on July 10, 2026.

The approval also isn't durvalumab's first entry in this disease. The FDA approved durvalumab with gemcitabine and cisplatin before surgery, followed by durvalumab afterward, on March 28, 2025. That regimen depends on cisplatin. The November 13 decision is the one built for the patients who can't use it.