AstraZeneca’s Imfinzi (durvalumab) plus BCG has been approved by the FDA for adults with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer — the first immunotherapy combination authorized for this group in the US. The POTOMAC Phase III trial showed a 32% reduction in risk of recurrence, progression or death (DFS HR 0.68) with a median follow‑up of 60.7 months. Safety was consistent with known profiles, did not impair BCG completion, and regulatory filings are under review in the EU, Japan and other regions.
FDA Approves First Immunotherapy Combination: Imfinzi (Durvalumab) Plus BCG For High‑Risk NMIBC
In the POTOMAC trial
AstraZeneca has received US Food and Drug Administration (FDA) approval for Imfinzi (durvalumab) used 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 is the first immunotherapy combination authorized in the US specifically for this patient population.
Key Trial Results Driving Approval
The approval was supported by data from the POTOMAC Phase III trial, presented at the ESMO 2025 Congress and published in The Lancet. Adding one year of Imfinzi to standard BCG induction and maintenance produced a 32% reduction in the risk of high‑risk disease recurrence, progression, or death compared with BCG alone (disease‑free survival hazard ratio [DFS HR] 0.68). The trial’s median follow‑up was 60.7 months, and the Imfinzi plus BCG regimen consistently demonstrated durable disease‑free survival benefits over that period.
Safety and Patient Experience
Safety findings for the combination matched known individual safety profiles for Imfinzi and BCG; no new safety signals were identified. Importantly, adding Imfinzi did not reduce patients’ ability to complete prescribed BCG courses and had no adverse impact on patient‑reported quality of life.
Regulatory And Ongoing Development
Regulatory submissions based on these data are under review in the European Union, Japan and other jurisdictions. AstraZeneca also recently reported positive top‑line results from the VOLGA Phase III trial in muscle‑invasive bladder cancer, and Imfinzi remains under investigation in the NIAGARA and NILE Phase III trials.
Dave Fredrickson, Executive Vice‑President of AstraZeneca’s Oncology Business Unit, 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. 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.”
Separately, AstraZeneca and Daiichi Sankyo recently received FDA approval for Datroway (datopotamab deruxtecan) to treat metastatic triple‑negative breast cancer, underscoring continued momentum in oncology approvals for both companies.
Source: Originally reported by Hospital Management (a GlobalData brand); POTOMAC results presented at ESMO 2025 and published in The Lancet. This summary is for informational purposes and is not medical advice. Clinicians should consult prescribing information and clinical guidelines when making treatment decisions.
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