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.
Bruce Levine, a professor in cancer gene therapy at the University of Pennsylvania, said that in addition to the reports submitted to the FDA, two abstracts published late last year in the journal Blood also cited a potential cancer risk associated with CAR-T therapy, which likely “forced the FDA’s hand.”
CAR-T — or chimeric antigen receptor T cell — therapy uses a patient’s own immune cells to treat certain blood cancers, such as leukemia, multiple myeloma and lymphoma. It involves harvesting the immune cells — in this case, T cells — then genetically altering them in a lab to make them target cancer cells, and finally reinfusing them back into the patient.
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