CAR T cell labels gain a boxed warning

CAR T cell therapies directed against CD19 and BCMA will now come with a boxed warning of the risk of T cell malignancies — including fatal cancers — but the risk remains low and the modality’s benefits remain high in the approved indications.

Last week, FDA issued safety labeling change notification letters to the manufacturers of CD19-directed CAR T cell therapies Breyanzi lisocabtagene maraleucel, Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, and to the manufacturers of BCMA-directed CAR T cell therapies Abecma idecabtagene vicleucel and Carvykti ciltacabtagene autoleucel. The five products are required to have a boxed warning stating that T cell malignancies have occurred following treatment...