Durvalumab + BCG approved for some NMIBC patients

The FDA approved durvalumab (Imfinzi, AstraZeneca) with Bacillus Calmette-Guerin for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC). The approval is based on POTOMAC, a randomized, open-label, multicenter Phase 3 trial that enrolled 1,018 patients with high-risk NMIBC after transurethral resection of bladder tumor. The FDA defined high-risk disease in the trial as T1 tumor, grade 3 or high-grade tumor, carcinoma in situ, or multiple, recurrent, and large tumors.

Patients were randomized 1:1:1 to durvalumab every 4 weeks for 13 cycles plus BCG induction and maintenance, BCG induction and maintenance alone, or another investigational regimen. The major efficacy end point was investigator-assessed disease-free survival, defined from randomization to recurrence of high-risk NMIBC, persistent carcinoma in situ, muscle-invasive bladder cancer, metastatic disease, or death.

Results of this trial showed that durvalumab plus BCG induction and maintenance significantly improved disease-free survival compared with BCG induction and maintenance alone, with a hazard ratio of 0.68 (95% CI, 0.50-0.93; two-sided P=0.0154). Median disease-free survival was not reached in either arm. The recommended durvalumab dose is 1,500mg every 4 weeks for 13 cycles for patients weighing at least 30kg, in combination with BCG induction and maintenance. Treatment should continue until high-risk recurrence, disease progression, unacceptable toxicity, or completion of 13 cycles. The label includes warnings for immune-mediated adverse reactions, infusion reactions, transplant complications, 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. May 28, 2026. Accessed August 24, 2026.