FDA Approves New CAR T-Cell Therapy for ALL

November 12, 2024

The U.S. Food and Drug Administration (FDA) approved obecabtagene autoleucel (Aucatzyl), a CD19-directed CAR T-cell immunotherapy developed by Autolus Inc., for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA based its approval on results from the FELIX trial, an open-label, multicenter study that evaluated adults with CD19-positive B-cell ALL. Among 65 patients assessed for efficacy, 27 (42%) achieved a complete response within three months. The median duration of response was 14.1 months (95% CI: 6.1, not reached).

The prescribing information includes a boxed warning for serious adverse events, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) and T-cell malignancies. In the trial, CRS occurred in 75% of patients while neurologic toxicities affected 64%; ICANS was reported in 24% of patients.

The review process utilized the Assessment Aid, a voluntary submission intended to streamline FDA’s assessment, and the therapy was granted regenerative medicine advanced therapy (RMAT) and orphan drug designations.