FDA Warns of T-Cell Malignancy Risk in CAR-T Immunotherapies | ASH Clinical News | American Society of Hematology
The U.S. Food and Drug Administration (FDA) issued a warning about the risk of T-cell malignancies in patients who have received BCMA- or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The warning followed the receipt of reports from clinical trials and post-marketing adverse event sources detailing T-cell malignancy occurrences in this patient population. A press release from the FDA noted that the benefits of these therapies still outweigh this risk, but the need for