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June 1, 2026

FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy

AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).

In the POTOMAC trial, one year of Imfinzi plus BCG reduced disease recurrence, progression or death risk by 32%. Credit: Sai Thaw Kyar / Shutterstock.com.