FDA approves durvalumab plus BCG for high-risk non-muscle invasive bladder cancer
The agency's May 28, 2026 approval covers adult patients with BCG-naïve, 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).1
The approval applies specifically to patients who have not previously received BCG therapy, as stated in the agency's record of the decision.
No additional details on trial data, dosing schedule, or further regulatory steps were included in the FDA's posted announcement.
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