FDA approval: Aucatzyl (from Catapult’s regulatory round-up for November 2024)
FDA has approved obecabtagene autoleucel (Aucatzyl) a CD19-directed chimeric antigen receptor (CAR) T cell therapy indicated for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia. Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a Risk Evaluation Mitigation Strategy (REMS) program. However, the FDA has added a boxed warning for cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and T cell malignancies to the prescribing information.
Published on the 3rd of december 2024. Read the entire Regulatory Round-up – November 2024 here.
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adelage (12 février 2025). FDA approval: Aucatzyl (from Catapult’s regulatory round-up for November 2024). ELSIBI. Consulté le 25 avril 2025 à l’adresse https://doi.org/10.58079/13axl