FDA Officials Recommend Long-Term Follow-Up for CAR-T Therapies in Autoimmune Diseases

February 2, 2026 — Global Biotech News

Silver Spring, MD, USA — Senior officials at the U.S. Food and Drug Administration (FDA) have urged biotechnology companies to implement long-term monitoring of patients receiving CAR-T cell therapies for autoimmune diseases. The recommendation, published in a commentary in Annals of Internal Medicine, highlights potential safety concerns, including risks of malignancies and fertility effects that may not emerge immediately after treatment.

CAR-T therapies, which involve genetically modifying a patient’s T cells to target disease-related immune cells, are increasingly being explored for conditions such as lupus, rheumatoid arthritis, and multiple sclerosis. While CAR-T has shown transformative results in oncology, regulators emphasize that autoimmune applications present unique challenges, particularly regarding long-term safety and immune system impact.

Photo by U.S. Food and Drug Administration

The FDA guidance encourages developers to design clinical trials with extended follow-up periods, robust data collection on late-onset adverse events, and strategies for ongoing patient monitoring. Industry experts note that this approach may affect future trial protocols, regulatory approvals, and post-marketing requirements for CAR‑T therapies beyond cancer indications.

Dr. Emily Nguyen, an FDA biologics reviewer, stated: “As we expand CAR-T therapies into non-oncologic indications, it is critical to balance innovation with vigilance. Long-term follow-up is essential to ensure patient safety and support informed decision-making by clinicians and patients.”

Photo by Thisisengineering on Unsplash

The recommendation is expected to shape the next generation of autoimmune CAR-T trials and reinforces the FDA’s commitment to proactive oversight as advanced cellular therapies move into broader clinical applications.

Source: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy — STAT News (February 2, 2026)