Skip to main content

FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder Cancer

On March 28, 2025, the Food and Drug Administration 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 and Safety

Efficacy was evaluated in NIAGARA (NCT03732677), a randomized, open-label, multicenter, Phase III 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 pre-specified 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-value <0.0001). Median OS was not reached in either arm (hazard ratio 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 1,500 mg every 3 weeks with chemotherapy (neoadjuvant treatment) and 1,500 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.

Expedited Programs

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

This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

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 or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.

Source: FDA

Posted: March 2025

Related articles

Imfinzi (durvalumab) FDA Approval History

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.