New MIBC Treatment Option: Durvalumab and Enfortumab Vedotin Approved

November 13, 2026 Dr. Michael Lee – Health Editor Health

Muscle-invasive bladder cancer patients ineligible for cisplatin chemotherapy gained a new combination treatment option on Friday when the US Food and Drug Administration approved perioperative durvalumab paired with neoadjuvant enfortumab vedotin.

Key Clinical Takeaways:

  • The FDA approved durvalumab combined with enfortumab vedotin for muscle-invasive bladder cancer on November 13, 2026.
  • The regimen targets patients who are ineligible for or have declined cisplatin-based chemotherapy.
  • The US Food and Drug Administration conducted its review through Project Orbis to facilitate international regulatory alignment.

Recurrence following radical cystectomy is a major clinical concern in muscle-invasive bladder cancer. A lot of us in the field have anticipated these findings for some time, according to David J. Benjamin, MD, a medical oncologist at Hoag Family Cancer Institute in Newport Beach, California, in an interview with Targeted Onc.

VOLGA: perioperative durvalumab and neoadjuvant enfortumab vedotin in MIBC — VJOncology

The combination provides another option for patients facing a very aggressive cancer, balancing the goal of a cure against long-term toxicity risks, Benjamin told Targeted Onc.

“I think it will provide another option for patients with [MIBC]. We know it is a very aggressive cancer, and it’s a balance between helping our patients get cured and not causing long-term toxicity.”

said David J. Benjamin, MD, a medical oncologist at Hoag Family Cancer Institute in Newport Beach, California, in an interview with Targeted Onc.

VOLGA Phase 3 Trial: Durvalumab + Enfortumab Vedotin Improves Survival in Cisplatin-Ineligible MIBC — OncoAlert 360

Safety data show that the combination regimen carries notable adverse events. Grade 3 or higher adverse events of any cause occurred in 71.1% of patients receiving the durvalumab and enfortumab vedotin combination, compared with 50.2% of patients in the control arm. Treatment-related grade 3 or higher adverse events appeared in 30.7% of patients in the combination group, as detailed in the US Food and Drug Administration approval documentation.

Durvalumab carries warnings and precautions for immune-mediated adverse reactions. These complications can affect multiple organ systems and potentially prove severe or fatal, alongside infusion-related reactions and embryo-fetal toxicity, per the US Food and Drug Administration.

Durvalumab, Tremelimumab, and Enfortumab Vedotin in Muscle-Invasive Bladder Cancer (VOLGA) — OncoMarks

Enfortumab vedotin brings its own set of critical risks. Patients face hazards including skin reactions, peripheral neuropathy, hyperglycemia, ocular disorders, and pneumonitis, according to the US Food and Drug Administration.

The new approval arrives as muscle-invasive bladder cancer treatments change rapidly. Enfortumab vedotin plus pembrolizumab received FDA approval in November 2025 for patients ineligible for cisplatin-based chemotherapy, following findings from the phase 3 EV-303/KEYNOTE-905 trial, indexed under NCT03924895.

In July 2026, the FDA expanded the perioperative pembrolizumab and enfortumab vedotin indication to all muscle-invasive bladder cancer patients regardless of cisplatin eligibility. That decision drew on data from the phase 3 KEYNOTE-B15/EV-304 trial, tracked as NCT04700124.

Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.

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