FDA Approves Imfinzi Plus BCG for High-Risk Bladder Cancer

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

The approval was based on findings from the phase 3 POTOMAC trial, which evaluated durvalumab plus BCG induction and maintenance compared with BCG induction and maintenance alone in patients with high-risk NMIBC following transurethral resection of bladder tumor. The data demonstrated a statistically significant improvement in disease-free survival, offering a new treatment option for patients with high-risk bladder cancer.

Disease-Free Survival Results in POTOMAC

In the phase 3 POTOMAC trial, durvalumab plus BCG induction and maintenance demonstrated a statistically significant improvement in disease-free survival compared with BCG induction and maintenance alone.

The hazard ratio for disease-free survival was 0.68 with a 95% confidence interval of 0.50 to 0.93 and a two-sided p-value of 0.0154, indicating a reduction in the risk of recurrence, progression or death with the durvalumab combination. Median disease-free survival was not reached in either treatment arm at the time of analysis.

Disease-free survival was defined as the time from randomization until recurrence of high-risk NMIBC, persistent carcinoma in situ, muscle-invasive bladder cancer, metastatic disease or death.

Phase 3 POTOMAC Trial Design

The POTOMAC trial was a randomized, open-label, multicenter phase 3 study that enrolled 1,018 patients with high-risk NMIBC following transurethral resection of bladder tumor.

High-risk NMIBC was defined as having one or more of the following features: T1 tumor, grade 3 or high-grade tumor, carcinoma in situ or multiple, recurrent and large tumors.

Patients were randomly assigned in a 1-to-1-to-1 ratio to receive either durvalumab every four weeks for 13 cycles plus BCG induction and maintenance, BCG induction and maintenance alone or an additional investigational combination regimen.

The major efficacy outcome measure was investigator-assessed disease-free survival.

Recommended Dose and Administration

The recommended dose of durvalumab for patients weighing at least 30 kilograms is 1,500 milligrams 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 completion of a maximum of 13 cycles.

Key Side Effects and Warnings

Safety findings for durvalumab include warnings and precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation and embryo-fetal toxicity.

These side effects and safety considerations are included in the prescribing information for patients receiving durvalumab in combination with BCG for high-risk NMIBC.

Clinical Monitoring Considerations

Healthcare professionals are advised to monitor patients closely for immune-mediated adverse reactions, which may affect multiple organ systems and require prompt recognition and management.

Infusion-related reactions may also occur during treatment with durvalumab. Additionally, embryo-fetal toxicity remains an important consideration in patients who may become pregnant during treatment.

References

1. “FDA Approves Durvalumab (Imfinzi) With BCG for High-Risk Non-Muscle Invasive Bladder Cancer.” U.S. Food and Drug Administration. May 28, 2026.

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