FDA Issues Warning on Secondary Cancer Risk in CAR-T Cell Therapy

Despite the warning, experts believe the benefits of the therapy continue to outweigh the risks.

The US Food and Drug Administration (FDA) has issued a warning about the possible risk of secondary cancers in patients treated with CAR-T cell therapy.
The FDA has sent notification letters to several manufacturers of these therapies, requiring them to add a “boxed warning” to the products’ prescribing information.
As of Monday, the FDA has received 25 reports of T-cell malignancy after treatment with CAR-T cell immunotherapies.
Patients and people participating in clinical trials who are receiving these therapies should be monitored “life-long” for any new malignancies, according to the FDA.
Despite the warning, many experts believe the benefits of CAR-T cell therapies continue to substantially outweigh the risks.