FDA approves durvalumab combination for cisplatin-ineligible muscle invasive bladder cancer
The FDA approved durvalumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer in adults who are ineligible for or refused cisplatin-based chemotherapy. In VOLGA, the hazard ratio for event-free survival was 0.51 against radical cystectomy alone.
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On November 13, 2026, the FDA approved durvalumab (Imfinzi, AstraZeneca) with enfortumab vedotin-ejfv 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. In VOLGA, the hazard ratio for event-free survival was 0.51 (95% CI: 0.38, 0.67) against radical cystectomy alone, the FDA said. The agency approved the application six weeks ahead of its goal date.
| Outcome | Median with durvalumab and enfortumab vedotin-ejfv | Median with radical cystectomy alone | Hazard ratio |
|---|---|---|---|
| Event-free survival | not reached (95% CI: 33.2, NR) | 12.1 months (95% CI: 7.6, 27.0) | 0.51 (95% CI: 0.38, 0.67) |
| Overall survival | not reached | not reached | 0.58 (95% CI: 0.40, 0.83) |
From the FDA's approval announcement of November 13, 2026, describing the VOLGA trial (NCT04960709).
Why it matters
Imfinzi's label, published Sep 07, 2026, lists durvalumab in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent Imfinzi after radical cystectomy, for adults with muscle invasive bladder cancer. The November 13 approval covers adults who are ineligible for or have refused cisplatin-based chemotherapy, a group that regimen does not name.
Efficacy results
The FDA said efficacy was evaluated in VOLGA (NCT04960709), a randomized, open-label trial. It randomized (1:1:1) 695 patients with muscle invasive bladder cancer who were candidates for radical cystectomy and who were ineligible for or refused cisplatin-based chemotherapy. Patients received neoadjuvant durvalumab and enfortumab vedotin-ejfv followed by adjuvant durvalumab, radical cystectomy alone, or an additional investigational combination regimen.
- Major efficacy outcome: event-free survival (EFS) by blinded independent central review assessment. Overall survival (OS) was an additional outcome.
- Median EFS: not reached (95% CI: 33.2, NR) with durvalumab and enfortumab vedotin-ejfv, and 12.1 months (95% CI: 7.6, 27.0) with radical cystectomy alone.
- EFS hazard ratio: 0.51 (95% CI: 0.38, 0.67); two-sided p-value < 0.0001.
- Median OS: not reached in either arm; hazard ratio 0.58 (95% CI: 0.40, 0.83); two-sided p-value 0.0027.
The FDA said the trial demonstrated statistically significant improvements in both EFS and OS compared with radical cystectomy alone.
Safety
The FDA said the durvalumab prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicities. Adverse reactions in more than 20% of patients on the combination, including laboratory abnormalities, included increased AST, increased ALT, decreased hemoglobin, rash, increased creatinine, pruritus, urinary tract infection, fatigue, diarrhea, nausea, peripheral neuropathy and alopecia, the FDA said.
Recommended dosage
For patients weighing 30 kg or more, the FDA lists durvalumab 1,500 mg every 3 weeks with enfortumab vedotin-ejfv 1.25 mg/kg (on Days 1 and 8 of each cycle) for 3 cycles before surgery, then durvalumab 1,500 mg alone every 4 weeks for up to 9 cycles after surgery. Treatment continues until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity, or a maximum of 9 cycles after surgery, the FDA said.
Review details
The FDA said the review was conducted under Project Orbis, with international partners. The application was granted priority review and used the Assessment Aid, a voluntary submission from the applicant. Full prescribing information for Imfinzi will be posted on Drugs@FDA, the FDA said.