FDA investigates safety of CAR-T cell immunotherapies
Drug Discovery World
NOVEMBER 30, 2023
The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients. The reports were received from clinical trials and postmarketing adverse event (AE) data sources.
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