Durvalumab Approved for Muscle Invasive Bladder Cancer
On March 28, 2025, the US Food and Drug Administration (FDA) approved durvalumab plus gemcitabine and cisplatin in the neoadjuvant setting, followed by single agent durvalumab in the adjuvant setting after radical cystectomy for patients with muscle invasive bladder cancer (MIBC). This regulatory decision was based on results from the phase 3 NIAGARA trial.
NIAGARA is a randomized, open-label, multicenter trial that enrolled 1063 patients with MIBC who were candidates for radical cystectomy and had not yet received systemic therapy for bladder cancer. Patients were randomized on a 1-to-1 basis to receive neoadjuvant chemotherapy either alone or with durvalumab, followed by surgery. After surgery, the durvalumab arm also received adjuvant durvalumab. The major efficacy outcome was event-free survival (EFS) by blinded independent central review, with overall survival as an additional efficacy measure.
At the interim analysis, there was a statistically significant improvement in EFS and OS in the durvalumab arm. The medium EFS of the durvalumab arm was not reached (95% confidence interval, “not reached” to “not reached”) vs 46.1 months in the chemotherapy alone arm (hazard ratio [HR], 0.68; 2-sided P-value < .0001). The median OS was not reached in either arm (HR, 0.75; 2-sided P-value = .0106). The adverse reactions were noted to be consistent with the previous safety profile of durvalumab plus platinum-based chemotherapy.
The recommended dose of durvalumab for patients weighing ≥ 30 kg is 1500 mg every 3 weeks with chemotherapy as neoadjuvant treatment and 1500 mg as a single agent every 4 weeks as adjuvant treatment (20 mg/kg; 20 mg/kg for patients weighing < 30 kg). Treatment should continue until disease progression precluding definitive surgery, recurrence, or unacceptable toxicity, or a maximum of 8 cycles after surgery.
Source:
FDA approves durvalumab for muscle invasive bladder cancer. Accessed on March 31, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer
