FDA officials recently approved durvalumab (Imfinzi; AstraZeneca) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle-invasive bladder cancer.1
The decision followed data from NIAGARA (NCT03732677), a randomized, open-label, multicenter, phase 3 trial that enrolled 1063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Patients were randomly assigned to receive neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery alone.
Median event-free survival was not reached (NR) (95% confidence interval [CI], NR-NR) in the durvalumab with chemotherapy arm compared with 46.1 months (95% CI, 32.2-NR) in the chemotherapy arm (hazard ratio [HR] 0.68 [95% CI, 0.56-0.82]; 2-sided P<.0001). The Imfinzi-based regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm. The Imfinzi-based perioperative regimen reduced the risk of death by 25%.
Reference
- FDA. FDA approves durvalumab for muscle invasive bladder cancer. March 28, 2025. Accessed April 1, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer
