Food and Drug Administration officials are advising drug developers to study the long-term effects of using CAR-T to treat patients with autoimmune conditions, out of concern the therapies could cause cancer or fertility issues.
The recommendations were outlined in an op-ed published Monday in the Annals of Internal Medicine. In it, Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, and two agency colleagues recommended that long-term studies be conducted when using CAR-T to treat autoimmune diseases “as is standard for genetic therapies and CAR T-cells for oncological indications.”
The paper does not specify how long autoimmune patients should be followed, but in cancer cases, the agency requires patients to be tracked for 15 years after the treatment is first administered.
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