FDA approval: Aucatzyl (from Catapult's regulatory round-up for November 2024)

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12 février 2025

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ELSIBI

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Hypothèses : carnets de recherches en Sciences humaines et sociales

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OpenEdition

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info:eu-repo/semantics/openAccess

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Therapy, Cellular Cells--Therapeutic use Cell therapy

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« FDA approval: Aucatzyl (from Catapult's regulatory round-up for November 2024) », ELSIBI, ID : 10.58079/13axl

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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 malig...

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