Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

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 cancer. Patients were randomized (1:1) to receive neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery alone.

The major efficacy outcome was event-free survival (EFS) by blinded independent central review. Overall survival (OS) was an additional efficacy outcome. At a prespecified interim analysis, the trial demonstrated a statistically significant improvement in EFS and OS. Median EFS was not reached (NR) (95% CI, NR-NR) in the durvalumab with chemotherapy arm and 46.1 months (95% CI, 32.2-NR) in the chemotherapy arm (hazard ratio, 0.68; 95% CI, 0.56-0.82; two-sided P<0.0001). Median OS was NR in either arm (hazard ratio, 0.75; 95% CI, 0.59-0.93; two-sided P=0.0106).

Adverse reactions were consistent with prior experience with durvalumab plus platinum-based chemotherapy.

The full prescribing information for durvalumab will be posted on Drugs@FDA. 

Based on a press release from the FDA.