FDA Warns of Increased Cancer Risk from CAR-T Therapy

The FDA has instructed several drugmakers to add a boxed warning to the prescribing information for CAR-T therapy, a type of cancer treatment, due to reports of rare blood cancers in patients who had previously received the therapy. Despite the warning, the FDA maintains that the overall benefits of CAR-T therapy outweigh its potential risks. The therapy, which uses a patient's own immune cells to target cancer cells, has been highly effective in treating certain blood cancers. Drugmakers are required to submit proposed label changes within 30 days, acknowledging the rare risk of blood cancers associated with CAR-T therapy. While the exact causal relationship between CAR-T therapy and cancer is still unclear, physicians may become more cautious in discussing the potential risk of developing secondary cancers with patients undergoing cancer treatment.