Tuesday, the FDA announced to impose a classwide black box warning following its investigation into secondary T-cell cancers arising from the use of existing CAR-T therapies.
“We consider this information to be “new safety information” as defined in section 505-1(b)(3) of the FDCA. Furthermore, we consider the serious risk of T cell malignancy to be applicable to all BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.”
In its January 19 notification letters, the agency stressed that the potential risk applies to all currently approved CAR-T products.
In ...