AstraZeneca’s Imfinzi Becomes First Immunotherapy Combination Approved in the U.S. for Early Bladder Cancer
AstraZeneca announced that the U.S. FDA approved Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC), making it the first and only approved immunotherapy combination for this early-stage bladder cancer setting. The approval was based on results from the Phase III POTOMAC trial, which showed that adding Imfinzi to standard BCG therapy reduced the risk of disease recurrence, progression, or death by 32% compared with BCG alone. This milestone expands Imfinzi’s role in curative-intent cancer treatment and provides a new option for patients at high risk of bladder cancer recurrence. 
AstraZeneca’s Imfinzi Becomes First Immunotherapy Combination Approved in the U.S. for Early Bladder Cancer