A chimeric antigen receptor (CAR) T cell therapy approved by the US Food and Drug Administration in 2022 for multiple myeloma has been given a boxed warning by the agency after patients treated with the drug developed secondary malignancies. The product, Carvykti (ciltacabtagene autoleucel), consists of a patient’s T cells that have been engineered to attach to the B cell maturation antigen (BCMA) on multiple myeloma calls and kill them. The FDA approved the therapy on the basis of deep and durable responses by patients taking the therapy.
