Secondary malignancy of T-cell origin after CAR T-cell therapy: EMA’s conclusions from the evaluation of 38 suspected cases

After a thorough evaluation of available data on secondary T-cell malignancies following CD19- or BCMA-directed CAR T-cell therapy, including 38 patient cases, EMA concluded that it is at least a reasonable possibility that malignancies of T-cell origin are causally related to these therapies. Based on the available data, and particularly taking the mechanisms and effects of these products into account, EMA concluded that it is a class effect, even if not all products had reported cases of T-cell malignancy by 11 April 2024. This picture is…