Posted by Michael Wonder on 04 Jul 2025
Imfinzi approved in the EU as first and only peri-operative immunotherapy for muscle-invasive bladder cancer
4 July 2025 - Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen versus neoadjuvant chemotherapy alone
AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union for the treatment of adult patients with resectable muscle-invasive bladder cancer in combination with gemcitabine and cisplatin as neo-adjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy.
