The required warning label comes less than two months after the Food and Drug Administration (FDA) made public an investigation into reports of T-cell malignancies — types of cancer in blood cells — including lymphoma and leukemia in people who received treatment with CAR-T therapies.
CAR-T is a gene therapy that works by extracting white blood cells known as T-cells from a patient, reengineering them in a lab to attack cancer cells and then infusing them back into the body. It’s used mainly to treat blood cancers such as multiple myeloma.
But the therapies already carry a warning for dangerous immune responses and neurological risks. The FDA found reports of secondary cancers in about 20 patients that they suspect were caused by CAR-T treatments, but it wasn’t definitive, and the agency noted more investigation was needed.
The therapy was first approved in 2017 and has been used in nearly 30,000 patients.
In letters sent to the manufacturers dated Jan. 19, the FDA noted the secondary cancers can lead to hospitalizations or death. The agency said the labels need to indicate the cancers “may present as soon as weeks following infusion, and may include fatal outcomes.”
The agency is allowing the therapies to stay on the market, a sign their benefits continue to outweigh the risks. The companies have 30 days to submit proposed changes to the label.
