FDA Warns of Increased Cancer Risk from CAR-T Therapy

The FDA has instructed several drugmakers to include a boxed warning on the prescribing information for CAR-T therapy, a 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 benefits of CAR-T therapy outweigh the potential risks. Drugmakers, including Novartis, Bristol Myers Squibb, Gilead Sciences, and Johnson & Johnson, have been directed to submit proposed label changes within 30 days. While the exact link between CAR-T therapy and cancer is not fully understood, experts believe the risk is likely very small, and the label change is expected to support physicians' discussions with patients about the potential risk of developing secondary cancers following cancer treatment.