Posted by Michael Wonder on 29 Nov 2023
FDA investigating serious risk of T-cell malignancy following BCMA directed or CD19 directed autologous chimeric antigen receptor (CAR) T cell immunotherapies
28 November 2023 - The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T-cell immunotherapies.
Reports were received from clinical trials and/or post-marketing adverse event data sources.
The FDA has determined that the risk of T-cell malignancies is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies.
