On May 28, 2026, the FDA approved durvalumab (Imfinzi) in combination with bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-naive, high-risk non-muscle invasive bladder cancer (NMIBC).
Efficacy and Safety
Efficacy was evaluated in the POTOMAC study (NCT03528694), a randomized, open-label, multicenter trial that enrolled 1018 patients with high-risk NMIBC following transurethral resection of bladder tumor. High-risk NMIBC was defined as having one of the following: T1 tumor, grade 3/high-grade tumor, carcinoma in situ (CIS), or multiple, recurrent, and large tumors. Patients were randomized (1:1:1) to receive either durvalumab every 4 weeks for 13 cycles plus BCG induction and maintenance, BCG induction and maintenance, or an additional investigational combination regimen.
The major efficacy outcome measure was investigator-assessed disease-free survival (DFS), which was defined as the time from the date of randomization until the date of first recurrence of high-risk NMIBC, persistent CIS, muscle-invasive bladder cancer, metastatic disease, or death.
A statistically significant improvement in DFS was observed with durvalumab plus BCG induction and maintenance treatment compared with BCG induction and maintenance treatment alone (hazard ratio, 0.68; 95% CI, 0.50-0.93; 2-sided P value .0154; median DFS not reached for either arm).
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 toxicities.
Recommended Dosage
The recommended durvalumab dose for patients with a body weight of ≥30 kg is 1500 mg every 4 weeks for 13 cycles in combination with BCG induction and maintenance treatment. Treatment should continue until recurrence of high-risk disease, disease progression, unacceptable toxicity, or a maximum of 13 cycles.
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 June 2, 2026. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder