FDA approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer
Regulatory approval: On May 28, 2026, the FDA approved durvalumab (Imfinzi) in combination with bacillus Calmette-Guerin (BCG) for adult patients with BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC). Approval was supported by POTOMAC (NCT03528694), where durvalumab+BCG improved investigator-assessed disease-free survival versus BCG alone (HR 0.68; 95% CI 0.50–0.93; p=0.0154; median DFS not reached in either arm).
FDA approval (May 28, 2026)
The US Food and Drug Administration (FDA) approved durvalumab (Imfinzi; AstraZeneca) plus bacillus Calmette-Guerin (BCG) for adult patients with BCG-naïve, high-risk non–muscle invasive bladder cancer (NMIBC).
Supporting evidence: POTOMAC
Efficacy and safety were evaluated in POTOMAC (NCT03528694), a randomized, open-label, multicenter trial enrolling 1,018 patients with high-risk NMIBC following transurethral resection of bladder tumor. High-risk NMIBC was defined as T1, Grade 3/high-grade, carcinoma in situ (CIS), or multiple, recurrent, and large tumors.
Patients were randomized (1:1:1) to:
- Durvalumab every 4 weeks for 13 cycles + BCG induction and maintenance
- BCG induction and maintenance
- An additional investigational combination regimen
The primary efficacy endpoint was investigator-assessed disease-free survival (DFS), defined as time to first recurrence of high-risk NMIBC, persistent CIS, muscle-invasive bladder cancer, metastatic disease, or death.
A statistically significant DFS improvement was observed with durvalumab+BCG vs BCG alone: HR 0.68 (95% CI 0.50–0.93), p=0.0154; median DFS not reached in either arm.
Label highlights
Prescribing information includes warnings/precautions for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicities.
Recommended dosage
For patients ≥30 kg: durvalumab 1,500 mg every 4 weeks for 13 cycles with BCG induction and maintenance, until recurrence/progression, unacceptable toxicity, or completion of 13 cycles.