Sydney, 19 March 2025 – Imugene Limited (ASX: IMU) has achieved a major milestone with the US Food and Drug Administration (FDA) granting Fast Track Designation for its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Why This Matters
The FDA’s Fast Track program is designed to accelerate the development and review of promising therapies that address serious conditions with unmet medical needs. This designation gives Imugene several key advantages, including:
- More frequent FDA meetings to streamline development.
- Rolling review of regulatory submissions, allowing faster assessment.
- Potential for Accelerated Approval and Priority Review, speeding up the approval process.
Azer-cel: A New Approach to CAR T Therapy
Azer-cel is a next-generation, off-the-shelf CAR T-cell therapy that overcomes the limitations of traditional autologous CAR T treatments. Instead of using a patient’s own cells—which can involve lengthy and complex manufacturing—azer-cel uses pre-manufactured donor T-cells, allowing for quicker treatment delivery.
Encouraging Phase 1b clinical trial data has shown strong efficacy, especially in patients who have already failed multiple treatments, including autologous CAR T therapy. Notably, azer-cel has demonstrated a manageable safety profile, with no cases of immune effector cell-associated neurotoxicity syndrome (ICANS) reported in key patient groups.
A Critical Step for DLBCL Patients
DLBCL is the most common and aggressive form of non-Hodgkin’s lymphoma, with a significant number of patients relapsing or becoming resistant to standard treatments. Azer-cel provides a novel and potentially life-changing option for these patients.
Imugene CEO Leslie Chong highlighted the significance of this milestone, stating:
“Receiving FDA Fast Track Designation is a testament to the transformative potential of azer-cel for patients battling relapsed or refractory DLBCL. We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible.”
With this regulatory green light, Imugene is now positioned to accelerate its development efforts and bring azer-cel to market as quickly as possible for patients in need.
