FDA signals cautious, tailored pathway for CAR‑T in autoimmune disease — calls for long follow‑up

FDA leaders signaled a willingness to support CAR‑T development for autoimmune disorders under a flexible regulatory framework while emphasizing patient safety and long‑term monitoring. The agency and CBER officials outlined a tailored approach that preserves scientific rigor but recognizes differences between oncology and autoimmune indications. Echoing that stance, FDA scientists and reviewers urged long‑term surveillance for autoimmune CAR‑T recipients—potentially mirroring multi‑year follow‑up used for gene therapies—citing theoretical risks such as secondary malignancies and reproductive effects. Developers should expect detailed safety plans and extended monitoring commitments in regulatory interactions.