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  6. FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
  1. Resources for Information | Approved Drugs

FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer

On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

Full prescribing information for Imfinzi will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in the POTOMAC study (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 randomized (1:1:1) to receive either durvalumab every four 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). DFS 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 to BCG induction and maintenance treatment alone (hazard ratio 0.68 [95% CI: 0.50, 0.93]; two-sided p-value 0.0154; 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 1,500 mg every four 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.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. 

This application was granted standard review.  FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.

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