The FDA has approved durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy, for adult patients with muscle-invasive bladder cancer.
The regulatory decision was supported by data from the phase 3 NIAGARA trial (NCT03732677). Findings showed that patients treated in the durvalumab arm experienced a median event-free survivla (EFS) that was not reached (NR; 95% CI, NR-NR) compared with 46.1 months (95% CI, 32.2-NR) for neoadjuvant chemotherapy alone (HR, 0.68; 95% CI, 0.56-0.82; 2-sided _P_ < .0001).
The median overall survival was not reached in either arm (HR, 0.75; 95% CI, 0.59-0.93; 2-sided _P_ = .0106).