Imfinzi-Enfortumab Vedotin Wins FDA Priority Review in Bladder Cancer

AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in combination with enfortumab vedotin has been accepted and granted Priority Review by the US Food and Drug Administration for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy, AstraZeneca announced (AZN ) on 25 September 2026.

The Prescription Drug User Fee Act (PDUFA) date, the FDA’s action date for its regulatory decision, is anticipated during the fourth quarter of 2026, according to the company. Per the announcement, the FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca, said: “This Priority Review reinforces the potential of Imfinzi to become the immunotherapy backbone treatment for muscle-invasive bladder cancer, where patients face high rates of recurrence despite bladder removal surgery.” She added that, if approved, the regimen would be the first perioperative treatment with enfortumab vedotin given only before surgery.

The filing is based on results from the VOLGA Phase III trial. In a planned interim analysis, perioperative treatment with Imfinzi in combination with neoadjuvant enfortumab vedotin demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival versus radical cystectomy, surgery to remove the bladder, with or without approved adjuvant treatment, the company reported. The safety and tolerability of the combination was consistent with the known safety profiles of the individual medicines, with no new safety signals identified.

AstraZeneca first disclosed the VOLGA high-level interim results on 14 May 2026. At that time, the company also reported that a second experimental arm, perioperative Imfinzi plus Imjudo (tremelimumab) combined with neoadjuvant enfortumab vedotin, showed a statistically significant and clinically meaningful improvement in event-free survival with a favourable trend for overall survival; those overall-survival data were not statistically significant at the interim analysis and will be formally reassessed at a subsequent analysis. Thomas Powles, MD, Professor, Chair of Barts Cancer Centre (QMUL), London, and International Coordinating Investigator for the trial, said in May: “The VOLGA results show that perioperative durvalumab significantly extends event-free survival and overall survival when combined with neoadjuvant enfortumab vedotin, with a manageable safety profile, compared to surgery for patients in this curative-intent setting.” Galbraith described VOLGA at the time as the company’s third positive readout in bladder cancer alongside the NIAGARA and POTOMAC trials.

Regulatory applications based on the VOLGA results are currently under review in the EU, Japan and several other countries, according to the company.

VOLGA Trial Design

VOLGA is a Phase III, randomised, open-label, multi-centre global trial evaluating perioperative Imfinzi with or without Imjudo in combination with neoadjuvant enfortumab vedotin as treatment for patients with MIBC undergoing radical cystectomy who are not eligible for or have declined cisplatin, compared with radical cystectomy with or without approved adjuvant therapy.

In the trial, 695 patients were randomised 1:1:1 to Arm 1 (three cycles of Imfinzi and enfortumab vedotin plus two cycles of Imjudo prior to surgery, followed by nine cycles of Imfinzi plus one cycle of Imjudo as adjuvant therapy), Arm 2 (three cycles of Imfinzi and enfortumab vedotin prior to surgery, followed by nine cycles of Imfinzi adjuvant monotherapy) and Arm 3, the comparator arm. The trial was conducted in 182 centres across 25 countries in Europe, North America, South America and Asia.

The dual primary endpoints are event-free survival for both experimental arms versus the comparator arm, defined as the time from randomisation to first recurrence following radical cystectomy, first progression in patients who did not undergo radical cystectomy, failure to undergo radical cystectomy in patients with residual disease, or death due to any cause. Secondary endpoints include overall survival, pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.

Disease Background and Existing Imfinzi Approvals

Approximately one in four patients with bladder cancer has muscle-invasive disease, in which the tumour invades the muscle wall of the bladder without distant metastases, according to the announcement. As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities, and the standard treatment for these patients has historically been radical cystectomy alone. Approximately 50% of MIBC patients who undergo bladder-removal surgery experience disease recurrence. Bladder cancer is the eighth most common cancer in the world, with more than 635,000 cases diagnosed each year, and around 15,000 patients will be treated for MIBC in the United States in 2026, per the company’s investor-relations epidemiology estimate.

Imfinzi is approved in more than 50 countries for patients with cisplatin-eligible MIBC based on the NIAGARA Phase III trial. In 2025, NIAGARA established a new standard of care by adding perioperative Imfinzi to neoadjuvant cisplatin-based chemotherapy and radical cystectomy, the company said. Imfinzi in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy is approved in the US, Japan and other countries for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer based on the POTOMAC Phase III trial; at the time of the May VOLGA disclosure, that indication was still under review in the US, EU, Japan and several other countries.

In July 2026, positive high-level results from the NILE Phase III trial showed Imfinzi plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival versus chemotherapy as first-line treatment for patients with PD-L1-high unresectable, locally advanced or metastatic urothelial cancer, the company said.

Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks its interaction with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. Since the first approval in May 2017, more than 470,000 patients have been treated with Imfinzi, according to the company, which said the VOLGA results will be presented at a forthcoming medical meeting.