Overview
- The FDA approved durvalumab (Imfinzi) with intravesical BCG for adults with BCG‑naive, high‑risk non‑muscle invasive bladder cancer on May 28, 2026, citing the phase 3 POTOMAC trial.
- POTOMAC randomized 1,018 patients and found the durvalumab+BCG arm cut the composite risk of recurrence, progression, or death by 32% and improved disease‑free survival (HR 0.68, 95% CI 0.50–0.93).
- The approved dosing is durvalumab 1,500 mg every 4 weeks for up to 13 cycles for adults weighing at least 30 kg, given with BCG induction and maintenance, and treatment must stop for recurrence, progression, or unacceptable toxicity.
- The label warns about immune‑mediated adverse reactions, infusion reactions, complications in prior allogeneic stem cell transplant recipients, and embryo‑fetal risk, which will affect patient selection and monitoring.
- Advocacy groups welcomed the approval as a new option to reduce early recurrences after transurethral resection, and the decision could drive changes in guidelines, payer coverage, and clinician practice as access and long‑term outcomes are tracked.