AstraZeneca has announced that its supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) has been accepted by the U.S. Food and Drug Administration (FDA) for Priority Review. This application aims to expand the treatment options for patients with muscle-invasive bladder cancer (MIBC).
The FDA grants Priority Review to drugs that show potential to significantly improve current treatments in terms of safety or effectiveness, address serious conditions, or enhance patient adherence. The FDA’s regulatory decision is expected in the second quarter of 2025.
MIBC, which affects approximately one in four bladder cancer patients, is characterized by the tumor’s invasion into the bladder’s muscle wall, without distant metastases. Standard treatment for MIBC involves neoadjuvant chemotherapy followed by radical cystectomy, but patients still face high recurrence rates and a poor prognosis after cystectomy.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the need for new treatment options for MIBC, noting that nearly half of patients experience cancer recurrence or progression despite curative-intent treatments. The Priority Review designation reflects the urgent need for such options and the promise of IMFINZI in potentially transforming MIBC care by being the first and only perioperative immunotherapy regimen that could delay recurrence and extend survival.
The sBLA is supported by data from the NIAGARA Phase III trial, which was presented at the 2024 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine. In the trial, IMFINZI was administered in combination with neoadjuvant chemotherapy before radical cystectomy and continued as adjuvant monotherapy after surgery. The study found that IMFINZI significantly reduced the risk of disease progression, recurrence, surgery non-completion, or death by 32% compared to chemotherapy and surgery alone, with an event-free survival (EFS) hazard ratio of 0.68 (p<0.0001). Two-year EFS was 67.8% for the IMFINZI regimen versus 59.8% for the chemotherapy-only group.
Furthermore, the IMFINZI regimen also demonstrated a 25% reduction in the risk of death, with an overall survival (OS) hazard ratio of 0.75 (p=0.0106). At two years, 82.2% of patients receiving IMFINZI were alive, compared to 75.2% in the comparator group.
IMFINZI was generally well tolerated, with no new safety concerns observed in both the neoadjuvant and adjuvant settings. Its combination with chemotherapy did not affect patients’ ability to complete the full course of chemotherapy or undergo surgery.
Regulatory submissions for IMFINZI in MIBC are also under review in the European Union, Japan, and several other countries.
Important Safety Information: IMFINZI® (durvalumab) and IMJUDO® (tremelimumab-actl) may cause severe and potentially fatal immune-mediated adverse reactions. These can affect any organ system or tissue and may arise at any time during treatment, even after discontinuation. Patients should be closely monitored for signs and symptoms of immune-mediated reactions, and appropriate interventions, including corticosteroid therapy, may be required. Specific risks include immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and other complications, which require careful management and monitoring. For full details on the risks and safety profile, refer to the prescribing information.
