FDA Grants Priority Review to Perioperative Imfinzi Plus Neoadjuvant Enfortumab Vedotin in Muscle-Invasive Bladder Cancer
核心洞察
AstraZeneca's supplemental Biologics License Application for perioperative Imfinzi plus enfortumab vedotin has been accepted and granted Priority Review by the FDA in muscle-invasive bladder cancer (搜索).
The filing covers patients ineligible for or who have declined cisplatin-based chemotherapy, with a PDUFA action date anticipated in the fourth quarter of 2026.
The application rests on VOLGA Phase III interim results showing statistically significant and clinically meaningful improvements in event-free survival and overall survival versus radical cystectomy.
AstraZeneca's supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) has been accepted and granted Priority Review by the US Food and Drug Administration for patients with muscle-invasive bladder cancer (搜索) (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The company announced the decision 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. The agency 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.
VOLGA Interim Data Underpin the Filing
The sBLA is based on results from the VOLGA Phase III trial, which will be presented at a forthcoming medical meeting. In a planned interim analysis, perioperative treatment with Imfinzi in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy, surgery to remove the bladder, with or without approved adjuvant treatment.
The safety and tolerability of Imfinzi plus EV 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 EV, showed a statistically significant and clinically meaningful improvement in EFS with a favourable trend for OS. 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 and 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."
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "This Priority Review reinforces the potential of Imfinzi to become the immunotherapy backbone treatment for muscle-invasive bladder cancer (搜索), where patients face high rates of recurrence despite bladder removal surgery. If approved, this would be the first perioperative regimen with enfortumab vedotin given only before surgery; a potentially new standard of care offering practice-changing efficacy and tolerability in this curative-intent setting."
Trial Design and Endpoints
VOLGA is a Phase III, randomised, open-label, multi-centre global trial evaluating perioperative Imfinzi with or without Imjudo in combination with neoadjuvant EV 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 EV, 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 EV 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 EFS for both experimental arms versus the comparator arm, defined as the time from randomisation to first recurrence post-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 OS (Arm 1 vs. Arm 3 and Arm 2 vs. Arm 3), pathologic complete response, disease-free survival and pathologic downstaging across both experimental arms.
An Unmet Need in Cisplatin-Ineligible Patients
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. As many as 50% of patients are ineligible for cisplatin-based chemotherapy due to impaired renal function or comorbidities. The standard treatment for these patients has historically been radical cystectomy alone but, despite undergoing this major surgery, patients experience high rates of recurrence and have a poor prognosis.
Bladder cancer is the eighth most common cancer in the world, with more than 635,000 cases diagnosed each year. The most common type is urothelial carcinoma (搜索), which begins in the urothelial cells of the urinary tract. In 2026, around 15,000 patients will be treated for MIBC in the United States.
In 2025, the NIAGARA Phase III trial established a new standard of care by adding perioperative Imfinzi to neoadjuvant cisplatin-based chemotherapy and radical cystectomy. However, up to half of patients are not eligible to receive cisplatin, and approximately 50% of MIBC patients who undergo bladder removal surgery experience disease recurrence. New treatment options that prevent both progression before surgery and recurrence after surgery are needed in this curative-intent setting.
Broader Imfinzi Development in Bladder Cancer
Regulatory applications based on the VOLGA results are currently under review in the EU, Japan and several other countries.
Imfinzi is approved in more than 50 countries for patients with cisplatin-eligible MIBC, based on the NIAGARA Phase III trial. 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 (搜索), based on the POTOMAC Phase III trial. 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 OS versus chemotherapy as first-line treatment for patients with PD-L1 (搜索) high unresectable, locally advanced or metastatic urothelial cancer.
Imfinzi is a human monoclonal antibody that binds to the PD-L1 (搜索) protein and blocks the interaction of PD-L1 with the PD-1 (搜索) and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. Since its first approval in May 2017, more than 470,000 patients have been treated with Imfinzi. The programme is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, bladder cancer, breast cancer, ovarian cancer and several gastrointestinal cancers.