FDA approval: Aucatzyl (from Catapult's regulatory round-up for November 2024)
Year: 2025
Type: other
Abstract: 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...
Source: Hypotheses (OpenEdition)
DOI: 10.58079/13axl
Author: Adelage
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6917927945
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