Durvalumab Plus BCG Earns FDA Approval For High-Risk NMIBC

The FDA has approved durvalumab (Imfinzi) plus Bacillus Calmette-Guérin (BCG) as a treatment for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who did not receive prior BCG, according to a news release from the agency.¹

Supporting the regulatory decision were findings from the phase 3 POTOMAC trial (NCT03528694), which evaluated the durvalumab-based combination among those with T1 tumor, grade 3/high-grade tumor, carcinoma in situ (CIS), or multiple, recurrent, and large tumors. The investigational regimen was assessed against BCG induction and maintenance or an investigational combination regimen of clinician’s choice.

Efficacy data revealed a significant improvement in disease-free survival (DFS) among patients who received the durvalumab-based regimen vs BCG alone, with an HR of 0.68 (95% CI, 0.50-0.93; P =.0154). The median DFS was not reached for the durvalumab or BCG-only arms.

Previous data presented at the European Society for Medical Oncology (ESMO) Congress 2025 showed that despite immature overall survival (OS) data at the time of the analysis, there was no detriment to OS with the addition of durvalumab to BCG induction and maintenance therapy (HR 0.80; 95% CI, 0.53–1.20).²

The recommended dose among patients with a body weight of 30 kg or greater is 1500 mg every 4 weeks for a maximum of 13 cycles plus BCG induction and maintenance. Treatment should persist in the absence of recurrence of high-risk disease, disease progression, or intolerable toxicity.

Additionally, immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicities are among warnings and precautions contained within the prescribing information.

References

1. FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer. News release. FDA. May 28, 2026. Accessed May 28, 2026. https://bit.ly/43wfdiu
2. De Santis M. Durvalumab (D) in combination with Bacillus Calmette-Guerin (BCG) for BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC): final analysis of the phase 3, open-label, randomized POTOMAC trial. Presented at: ESMO 2025 Congress; October 17-20, 2025; Berlin, Germany. Abstract LBA108.