AZ’s Imfinzi® (durvalumab) US-Approved for Muscle Invasive Bladder Cancer

On 28 March 2025, the US FDA approved AstraZeneca’s Imfinzi® (durvalumab) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer (MIBC).

AstraZeneca’s sBLA for Imfinzi® for the MIBC indication was granted priority review by the FDA in December 2024.  In February 2025, Australia’s TGA accepted for review an indication expansion of Imfinzi® for MIBC.