FDA
FDA approves Imfinzi plus BCG for high-risk non-muscle invasive bladder cancer
High-risk non-muscle invasive bladder cancer (NMIBC) is associated with a substantial risk of recurrence and progression despite treatment with intravesical Bacillus Calmette-Guerin (BCG). On May 28, 2026, FDA approved a new indication for Imfinzi (durvalumab) in combination with BCG for adults with BCG-naïve, high-risk NMIBC, extending the role of immune checkpoint inhibition into a setting where treatment goals focus on preventing recurrence and disease progression while preserving the bladder.
The decision was based on results from the phase 3 POTOMAC trial, which enrolled 1,018 patients with high-risk NMIBC following transurethral resection of bladder tumor. High-risk disease included T1 tumors, high-grade tumors, carcinoma in situ, or multiple, recurrent, or large tumors.
Patients treated with Imfinzi plus BCG experienced significantly longer disease-free survival than those receiving BCG alone. The combination reduced the risk of recurrence, progression to muscle-invasive or metastatic disease, or death by 32% (hazard ratio, 0.68; 95% confidence interval, 0.50-0.93; P=.0154). Median disease-free survival was not reached in either treatment arm at the time of analysis.
The Imfinzi 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.
Imfinzi is administered at a dose of 1,500 mg every four weeks for up to 13 cycles in combination with BCG induction and maintenance therapy. Treatment should continue until recurrence of high-risk disease, disease progression, unacceptable toxicity, or completion of 13 cycles.
Source: U.S. Food and Drug Administration. (2026, May 28). FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer