FDA okays AstraZeneca’s bladder cancer drug Imfinzi Plus BCG

First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death

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 Non-Muscle-Invasive Bladder Cancer who are BCG-naïve.

The approval marks the first immunotherapy combination regimen approved in the United States for this patient population, representing a significant advancement in the treatment of early-stage bladder cancer.

The decision is based on positive results from the POTOMAC Phase III Trial, which were presented at the ESMO Congress 2025 and subsequently published in The Lancet.

In the study, the addition of Imfinzi to BCG induction and maintenance therapy for one year reduced the risk of high-risk disease recurrence, progression, or death by 32% compared with BCG therapy alone. 

The improvement was reflected in a disease-free survival hazard ratio of 0.68. With a median follow-up of more than five years (60.7 months), the Imfinzi-based regimen demonstrated sustained disease-free survival benefits.

The safety profile of Imfinzi combined with BCG was consistent with the known profiles of the individual therapies, and no new safety concerns were identified. Importantly, the addition of Imfinzi did not affect patients’ ability to complete BCG treatment courses or negatively impact patient-reported quality of life.

Regulatory submissions based on the POTOMAC data are currently under review in the European Union, Japan, and other international markets.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said the decision brings the first immunotherapy combination regimen to patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer and builds on the positive impact Imfinzi has already demonstrated in muscle-invasive disease.