FDA Approves Imfinzi for Muscle-Invasive Bladder Cancer

The FDA has approved durvalumab (Imfinzi, AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adults with muscle-invasive bladder cancer.

Efficacy was evaluated in NIAGARA (ClinicalTrials.gov Identifier: NCT03732677), a randomized, open-label, multicenter, phase 3 trial enrolling 1,063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder