Posted by Michael Wonder on 29 Mar 2025
FDA approves durvalumab for muscle invasive bladder cancer
28 March 2025 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neo-adjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer.
Efficacy was evaluated in NIAGARA, a randomised, open-label, multi-centre, Phase 3 trial enrolling 1,063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer.
