"FDA Investigates Secondary Cancer Risk of CAR-T Therapy"

The FDA has issued a warning about the potential risk of secondary cancers in cancer patients treated with CAR-T cell therapy, requiring manufacturers to add a "boxed warning" to the products' prescribing information. The agency has received reports of T-cell malignancies after treatment with these therapies, but emphasizes that the overall benefits still outweigh the risks. Patients receiving these therapies should be monitored for life, and healthcare providers are urged to report any new malignancies. While the risk appears to be low, the FDA is investigating and updating guidance as needed, and experts believe the benefits of CAR-T therapies continue to outweigh the risks.