STAT+: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy

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Source: STAT News

Original: https://www.statnews.com/2026/02/02/fda-long-term-follow-up-studies-car-t-therap...

Published: Mon, 02 Feb 2026 22:00:35 +0000

FDA officials are pushing for long-term follow-up of patients with autoimmune diseases who receive CAR-T therapy. They advise drug developers to study the long-term effects of this therapy in autoimmune conditions. They fear that CAR-T therapy could bring risks for these patients. CAR-T therapy is being tested for autoimmune diseases such as systemic lupus erythematosus, myasthenia gravis or multiple sclerosis. Patients after CAR-T therapy need long-term monitoring to detect delayed side effects, such as fatigue, changes in immune functions or neurological symptoms. Some cancer patients remain in complete remission for more than 9 or 12 years after therapy.