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 malig...