The FDA recently required a classwide boxed warning on all commercial chimeric antigen receptor (CAR) T-cell therapies after an investigation revealed a link between the treatments and secondary malignancies.
The agency issued letters to the manufacturers of all six CAR-T therapies on the market, requiring label updates to include T-cell malignancies in the boxed warning section. “FDA has determined that the serious risk of T-cell malignancies is applicable to all currently approved