Tag

Secondary Malignancies

All articles tagged with #secondary malignancies

health2 years ago

"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.

health2 years ago

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.