FDA says cancer treatment CAR-T therapy may increase risk of cancer

The agency is requiring drugmakers to add a warning label to its CAR-T therapy products, but it noted that the benefits of the treatment still outweigh the potential risks.

The Food and Drug Administration this week told several drugmakers to add a boxed warning — the agency’s strongest safety label — to the prescribing information for a type of cancer treatment called CAR-T therapy, saying the treatment itself may increase a person’s risk of cancer.

Carly Kempler, a spokesperson for the FDA, said that, despite the warning, "the overall benefits of these products continue to outweigh their potential risks."

The agency’s decision to update the labels was based on reports of rare blood cancers in patients who had previously gotten CAR-T therapy, Kempler said. As of Monday, the agency had received 25 reports of the blood cancers in CAR-T patients, she said.