Azercabtagene zapreleucel granted FDA fast track designation for the treatment of patients with R/R DLBCL

On March 19, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation to azercabtagene zapreleucel (azer-cel), an off-the-shelf, CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.¹ This announcement is supported by findings from a phase Ib trial.

Phase Ib trial

Clinical data from an ongoing phase Ib trial have shown considerable promise, especially in patients who have not responded to multiple previous therapies, including autologous CAR T. Azer-cel incorporates lymphodepletion chemotherapy and interleukin-2 (IL-2) to improve CAR T persistence and efficacy. The safety profile was manageable, with no instances of immune effector cell-associated neurotoxicity syndrome (ICANS).¹ 

Azer-cel is designed to address the logistical issues associated with autologous CAR T therapies, such as extended manufacturing times and restricted patient access. By utilizing pre-manufactured donor T-cells, azer-cel enables swift treatment delivery.¹