FDA Issues Fast Track Designation for New CAR T-Cell Therapy for Relapsed Refractory DLBCL

The FDA has granted Fast Track Designation to the chimeric antigen receptor (CAR) T-cell therapy azercabtagene zapreleucel (azer-cel) for the management of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Imugene Limited, the immuno-oncology company which is developing azer-cel, issued a press release announcing the FDA’s decision.

Azer-cel is an allogeneic, CD19-targeting CAR T-cell therapy for DLBCL and other blood cancers. It applies a novel approach of combining lymphodepletion chemotherapy with interleukin-2 to bolster the agent’s efficacy, especially against disease resistant to multiple therapy lines. It is also designed to be a faster and more accessible treatment option for patients than autologous CAR T-cell therapy.

An ongoing phase 1b trial has reported encouraging efficacy data from azer-cel against DLBCL, especially for patients with disease for which several previous therapies, including autologous CAR T-cell therapy, have been unsuccessful. Clinical investigations have also found azer-cel to have a manageable safety profile and an absence in key patient cohorts of immune effector cell-associated neurotoxicity syndrome.

“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,” remarked Leslie Chong, chief executive officer and managing director of Imugene.

Reference

Azer-cel granted FDA Fast Track Designation in blood cancer DLBCL. News release. Imugene Limited. March 19, 2025. Accessed March 25, 2025. https://company-announcements.afr.com/asx/imu/cb54785a-0444-11f0-9779-b6359b194da9.pdf