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 (FDA) for patients with Muscle-Invasive Bladder Cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy.

The FDA’s decision is based on results from the Phase 3 VOLGA trial, in which perioperative treatment with Imfinzi and neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in Event-Free Survival (EFS) and Overall Survival (OS) compared with radical cystectomy, with or without approved adjuvant treatment. The FDA’s regulatory decision is expected in the fourth quarter of 2026.

MIBC is a form of bladder cancer in which the tumour has invaded the muscle wall of the bladder without distant metastases. Approximately one in four bladder cancer patients has muscle-invasive disease, while up to half of patients may be ineligible for cisplatin-based chemotherapy because of impaired renal function or other comorbidities.

For patients unable to receive cisplatin, radical cystectomy has historically been a key treatment approach. However, recurrence remains a significant concern following bladder removal, creating a need for treatment strategies that can reduce the risk of disease progression and recurrence around surgery.

The VOLGA trial evaluated perioperative Imfinzi, with or without Imjudo (tremelimumab), in combination with neoadjuvant EV in patients with MIBC who were undergoing radical cystectomy and were not eligible for or had declined cisplatin-based chemotherapy. The global, randomised, open-label Phase III study enrolled 695 patients across 182 centres in 25 countries. 

Patients were randomised into three treatment groups. One experimental arm received Imfinzi and EV with Imjudo before surgery, followed by Imfinzi and Imjudo after surgery. The second received Imfinzi and EV before surgery, followed by Imfinzi monotherapy as adjuvant treatment. The comparator arm received radical cystectomy with or without approved adjuvant therapy.

The trial’s dual primary endpoints were EFS for both experimental arms compared with the comparator arm. Secondary endpoints included OS, pathologic complete response, disease-free survival and pathologic downstaging.

In a planned interim analysis, the Imfinzi plus neoadjuvant EV regimen achieved statistically significant and clinically meaningful improvements in both EFS and OS versus the comparator arm. The safety and tolerability profile was consistent with the established profiles of the individual medicines, with no new safety signals identified. 

The other experimental regimen, comprising Imfinzi, Imjudo and neoadjuvant EV, also demonstrated a statistically significant improvement in EFS and a favourable trend in OS at the interim analysis; however, the OS result was not statistically significant at that stage and will be reassessed in a subsequent analysis. 

If approved, the Imfinzi and EV regimen would expand perioperative treatment options for patients with MIBC who cannot receive cisplatin-based chemotherapy. AstraZeneca said regulatory applications based on the VOLGA results are also under review in the European Union, Japan and other countries. 

Imfinzi is already approved in multiple countries for MIBC in patients eligible for cisplatin-based chemotherapy, based on the Phase 3 NIAGARA trial. In the US, the FDA also approved durvalumab in combination with Bacillus Calmette-Guérin (BCG) in May 2026 for adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer. 

The regulatory landscape for MIBC has also expanded in the US. In July 2026, the FDA approved pembrolizumab, or pembrolizumab with berahyaluronidase alfa-pmph, in combination with enfortumab vedotin as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with MIBC who are candidates for surgery.

Imfinzi is a human monoclonal antibody targeting the PD-L1 protein. By blocking interactions involving PD-L1, the medicine is designed to counter tumour-mediated immune suppression and support an anti-tumour immune response.

AstraZeneca continues to evaluate Imfinzi across multiple cancer types and treatment settings, including bladder, lung, liver, gastrointestinal and other cancers. The company is also investigating Imfinzi in combination with other immunotherapies and targeted treatment approaches.