The FDA has called for a classwide boxed warning on all commercial chimeric antigen receptor (CAR) T-cell therapies after an investigation into the potential for secondary malignancies. The agency issued letters on Jan. 19 to the manufacturers of all six CAR-T therapies currently on the market, requiring label updates to include T-cell malignancies in the boxed warning section.
The warning must state that “T-cell malignancies may occur following treatment with BCMA- and CD19-directed