FDA Approves Durvalumab Plus BCG for BCG-Naïve Patients With Non-Muscle Invasive Bladder Cancer
- Clinical Summary: Design/Population: The phase 3 POTOMAC trial evaluated durvalumab plus BCG induction and maintenance vs BCG alone in BCG-naïve patients with high-risk non–muscle-invasive bladder cancer.
- Key Outcomes: Durvalumab plus BCG significantly improved disease-free survival compared with BCG alone, leading to FDA approval.
- Clinical Relevance: This approval introduces an immunotherapy-based combination option for patients with high-risk non-muscle invasive bladder cancer in the BCG-naïve setting.
On May 28, 2026, the US Food and Drug Administration (FDA) approved durvalumab (Imfinzi; AstraZeneca) plus Bacillus Calmette-Guerin (BCG) for BCG-naïve patients with high-risk non-muscle invasive bladder cancer. This approval was based on results from the phase 3 POTOMAC study.
In this open-label, multicenter study, 1018 patients who underwent transurethral resection of bladder tumor were randomized 1:1:1 to receive durvalumab once every 4 weeks for 13 cycles plus BCG induction and maintenance, BCG induction and maintenance alone, or an investigational combination regimen. The primary end point was investigator-assessed disease-free survival (DFS), defined as time to recurrence, persistent carcinoma in situ, muscle-invasive bladder cancer, metastatic disease, or death.
At analysis, median DFS was not reached in either treatment arm (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.50 to 0.93; P = .0154).
The recommended dose of durvalumab is 1500 mg administered intravenously once every 4 weeks for up to 13 cycles (for patients weighing at least 30 kg) in combination with BCG induction and maintenance therapy.
The prescribing information includes warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
Source:
US Food and Drug Administration. FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer. Accessed on May 28, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder
