FDA Investigates Potential Cancer Risks of CAR-T Therapy

The FDA has issued a warning stating that a type of cancer treatment called chimeric antigen receptor (CAR) T-cell immunotherapy may sometimes lead to the development of new blood cancers. The agency has received 19 reports of such cases and is currently investigating the risk of T-cell malignancies with serious outcomes. While CAR-T treatments have saved the lives of many patients with blood cancers, the FDA is considering whether regulatory action is necessary. Patients receiving these treatments should be monitored for new malignancies for the rest of their lives, and any suspected adverse events should be reported to the FDA.