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

FDA

28 May 2026 - Today, the FDA 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.

Efficacy was evaluated in the POTOMAC study, a randomised, open-label, multi-centre trial that enrolled 1,018 patients with high-risk non-muscle invasive bladder cancer following transurethral resection of bladder tumour.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Registration