STAT+: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy
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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.\u00a0<\/p>\n
The recommendations were outlined in an op-ed published Monday<\/a> in the Annals of Internal Medicine. In it, Vinay Prasad, head of the FDA\u2019s 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 \u201cas is standard for genetic therapies and CAR T-cells for oncological indications.\u201d\u00a0<\/p>\n 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.\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n