FDA

Imfinzi combo OK’d for muscle-invasive bladder cancer

April 8, 2025

FDA approved Imfinzi (durvalumab), in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for the treatment of adults with muscle-invasive bladder cancer (MIBC).

Efficacy

Approval for the new indication was based on data from the randomized, open-label phase 3 NIAGARA study (NCT03732677), which included 1,063 patients who were candidates for radical cystectomy and who’d not received prior systemic chemotherapy or immune-mediated therapy for MIBC or non-MIBC.

Study participants were randomized to receive either:

• neoadjuvant Imfinza 1,500 mg plus gemcitabine 1,000 mg/m² and cisplatin 70 mg/m² q3wks for four cycles prior to surgery, followed by Imfinzi 1,500 mg q4wks as a single agent adjuvant treatment for up to eight cycles after surgery (n = 533), or
• neoadjuvant gemcitabine 1,000 mg/m² and cisplatin 70 mg/m² q3wks for four cycles prior to surgery, without adjuvant treatment (n = 530)

The major efficacy outcome measure was event-free survival (EFS) by blinded independent central review. Overall survival (OS) was an additional efficacy outcome measure.

At a pre-specified interim analysis, the study demonstrated a statistically significant improvement in EFS and OS in the Imfinzi plus gemcitabine and cisplatin arm vs. the gemcitabine and cisplatin arm.

Safety

The most common adverse reactions reported during the trial (≥20% of patients with MIBC) were decreased hemoglobin, decreased neutrophils, increased creatinine, decreased sodium, nausea, increased ALT, decreased calcium, decreased platelets, fatigue, increased potassium, decreased lymphocytes, increased AST, constipation, decreased magnesium, decreased appetite, increased alkaline phosphate, rash, pyrexia, diarrhea, vomiting, and abdominal pain.

Sources:

Imfinzi (durvalumab) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761069s050lbl.pdf Revised March 2025. Accessed April 7, 2025.

Imfinzi® (durvalumab) approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer. [News release]. 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-the-us-for-bladder-cancer.html