On May 28, 2026, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor 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 phase III POTOMAC study (ClinicalTrials.gov identifier NCT03528694), a randomized, open-label, multicenter trial that enrolled 1,018 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 randomly assigned (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. Disease-free survival 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 disease-free survival was observed with durvalumab plus BCG induction and maintenance treatment compared to BCG induction and maintenance treatment alone (hazard ratio = 0.68; 95% confidence interval = 0.50–0.93; two-sided P value = .0154; median disease-free survival 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.
The recommended durvalumab dose for patients with a body weight of ≥ 30 kg is 1,500 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.
