AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).

This marks the first approved immunotherapy combination for this patient segment in the US.

The approval relies on positive data from the POTOMAC Phase III trial, which was presented at the European Society for Medical Oncology (ESMO) Congress 2025 and published in The Lancet.

In the trial, adding one year of Imfinzi to BCG induction and maintenance therapy resulted in a 32% reduction in the risk of high-risk disease recurrence, progression or death compared to BCG alone.

This was based on a disease-free survival hazard ratio of 0.68. The median follow-up period was over five years (60.7 months), and the Imfinzi regimen consistently showed disease-free survival benefits.

The safety profile of Imfinzi combined with BCG matched the known safety profiles of each drug individually, with no new signals identified.

The addition of Imfinzi did not impact patients’ ability to complete BCG courses or affect patient-reported quality of life.

Regulatory filings based on these results are under review in the European Union (EU), Japan, and other countries.

AstraZeneca previously shared positive top-line results from the VOLGA Phase III trial in muscle-invasive bladder cancer and continues additional investigations with Imfinzi in the NIAGARA and NILE Phase III trials.

AstraZeneca oncology haematology business unit executive vice-president Dave Fredrickson said: “Today’s approval for Imfinzi brings the first immunotherapy combination regimen to patients in the US with BCG-naïve, high-risk non-muscle-invasive bladder cancer, an early setting that builds on the positive impact Imfinzi is already having in muscle-invasive disease.

“The early and sustained disease-free survival benefit demonstrated by Imfinzi plus BCG in the POTOMAC trial is an important advance for patients at risk of early disease recurrence and signals a shift in the standard of care.”

Last month, AstraZeneca and Daiichi Sankyo secured approval from the FDA for Datroway (datopotamab deruxtecan) to treat metastatic triple-negative breast cancer (TNBC).