AstraZeneca has secured a second bladder cancer nod in the EU for its immunotherapy Imfinzi (durvalumab), expanding its presence in the bladder cancer market beyond its prior U.S. approval in the muscle-invasive setting. The European Commission approved Imfinzi as the first and only peri‑operative immunotherapy for adults with resectable muscle‑invasive bladder cancer (MIBC), in combination with gemcitabine and cisplatin before radical cystectomy and as monotherapy after surgery. This EU approval in July 2025 follows the U.S. FDA nod in March 2025, which also cleared the same Imfinzi‑based peri‑operative regimen for MIBC, making it the first immunotherapy regimen approved in this peri‑operative setting. The approvals are based on the NIAGARA Phase III trial, which showed a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death, along with statistically significant event‑free and overall survival benefits. Analysts see this second bladder ...
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