AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) and granted it Priority Review. The application seeks approval for IMFINZI as a treatment for patients with muscle-invasive bladder cancer (MIBC).
The Priority Review designation is reserved for medicines that could significantly enhance treatment outcomes, improve safety, or address serious conditions. The FDA’s decision on the application is expected in the second quarter of 2025.
MIBC: An Urgent Need for Advanced Treatments
Bladder cancer with muscle invasion affects approximately 25% of bladder cancer patients, translating to roughly 117,000 individuals receiving treatment with curative intent annually. Standard treatment involves neoadjuvant chemotherapy followed by radical cystectomy. However, even with these measures, recurrence rates remain high, and prognosis is poor.
Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology R&D, stated:
“Nearly half of patients with MIBC experience recurrence or progression despite curative-intent treatment, including bladder removal. The Priority Review designation underscores the critical need for new options and highlights IMFINZI’s potential as the first perioperative immunotherapy regimen to delay recurrence and extend survival in this setting.”
Data Supporting IMFINZI’s Efficacy
The sBLA submission is based on results from the Phase III NIAGARA trial, presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine.
The trial evaluated patients treated with IMFINZI in combination with neoadjuvant chemotherapy before radical cystectomy, followed by IMFINZI as adjuvant monotherapy. This was compared to neoadjuvant chemotherapy alone prior to cystectomy.
Key findings from the NIAGARA trial include:
- Event-Free Survival (EFS):
- IMFINZI reduced the risk of disease progression, recurrence, failure to undergo surgery, or death by 32% (hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.56–0.82; p < 0.0001).
- Median EFS was not reached for the IMFINZI group, compared to 46.1 months for the comparator arm.
- An estimated 67.8% of IMFINZI-treated patients were event-free at two years versus 59.8% in the comparator arm.
- Overall Survival (OS):
- IMFINZI reduced the risk of death by 25% (OS HR 0.75; 95% CI 0.59–0.93; p = 0.0106).
- Median OS was not reached in either arm.
- At two years, 82.2% of patients treated with IMFINZI were alive, compared to 75.2% in the comparator group.
IMFINZI was generally well-tolerated, and no new safety concerns were observed. The therapy did not impact patients’ ability to complete chemotherapy or undergo surgery.
A Global Impact
Regulatory reviews for IMFINZI based on the NIAGARA trial results are underway in the European Union, Japan, and other countries. If approved, IMFINZI would represent a transformative option in the treatment of MIBC, addressing a critical unmet need in oncology care.
Safety Information
IMFINZI and its combination therapies may cause severe or fatal immune-mediated adverse reactions affecting various organ systems. Regular monitoring of liver enzymes, creatinine, ACTH, and thyroid function is essential. Adverse reactions should be managed with corticosteroids or other systemic immunosuppressants as necessary. For detailed safety and dosing information, healthcare professionals are encouraged to consult the full U.S. prescribing information.
AstraZeneca’s Commitment
AstraZeneca continues its efforts to bring innovative immunotherapy options to patients. The approval of IMFINZI for MIBC could redefine the standard of care for a condition with historically limited treatment success, offering renewed hope for patients and healthcare providers alike.
