Imugene Limited (ASX:IMU) Granted FDA Fast Track Designation for Azer-cel
FDA Fast Track Designation
Imugene Limited (ASX:IMU) has been granted Fast Track Designation by the US Food and Drug Administration (FDA) for its allogeneic CAR T-cell therapy, azer-cel, targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Azer-cel Therapy
Azer-cel is an off-the-shelf, CD19-directed CAR T-cell therapy engineered to overcome the logistical challenges of autologous CAR T therapies. Clinical data from the ongoing Phase 1b trial has shown significant promise, especially in patients who have failed multiple prior therapies, including autologous CAR T.
Executive Comments
Leslie Chong, Managing Director and CEO of Imugene, stated, “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.”
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