FDA Investigates Potential Cancer Risk of Cutting-Edge CAR-T Therapy

The US Food and Drug Administration (FDA) is investigating the potential risk of a cutting-edge cancer treatment, CAR-T cell therapy, causing secondary malignancies. The therapy uses harmless viruses to deliver new genetic material into cells, but there is a theoretical risk that these viruses could activate cancer genes. The FDA has suggested lifelong monitoring for patients receiving CAR-T cell therapies and stated that the benefits of these treatments still outweigh the potential risks. Pharmaceutical companies such as Novartis, Bristol Myers Squibb, and Johnson & Johnson, which manufacture approved CAR-T cell therapies, have not found evidence linking their products to secondary malignancies. However, experts acknowledge the need for more information and caution that the occurrence of such cases is likely to be rare.