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FDA Approves Durvalumab for Muscle Invasive Bladder Cancer

Evidence for efficacy is based on the results from the NIAGARA study
02 May 2025
Immunotherapy
Urothelial Cancer

On 28 March 2025, the US Food and Drug Administration (FDA) 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 (MIBC).

Efficacy was evaluated in NIAGARA (NCT03732677), a randomised, open-label, multicentre, phase III study enrolling 1063 patients who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Patients were randomised 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 pre-specified interim analysis, the study demonstrated a statistically significant improvement in EFS and OS. Median EFS was not reached (NR; 95% confidence interval [CI] NR, NR) in the durvalumab with chemotherapy arm and 46.1 months (95% CI 32.2, NR) in the chemotherapy arm (hazard ratio [HR] 0.68, 95% CI 0.56, 0.82; two-sided p-value < 0.0001). Median OS was not reached in either arm (HR 0.75, 95% CI 0.59, 0.93; two-sided p-value = 0.0106).

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

The recommended durvalumab dose for patients with a body weight of ≥30 kg is 1500 mg every 3 weeks with chemotherapy (neoadjuvant treatment) and 1500 mg as a single agent every 4 weeks (adjuvant treatment). The recommended durvalumab dose for patients with a body weight <30 kg is 20 mg/kg with chemotherapy every 3 weeks (neoadjuvant treatment) and 20 mg/kg as a single agent every 4 weeks (adjuvant treatment). Treatment should continue until disease progression that precludes definitive surgery, recurrence, or unacceptable toxicity or a maximum of 8 cycles after surgery.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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