FDA Scales Back CAR-T REMS Programs in Response to Recommendations

Researchers at Dana-Farber Cancer Institute presented findings at the American Society for Transplantation and Cellular Therapy (ASTCT) 80/20 Workshop in June 2023, where a consensus emerged on the need for simplification and streamlining of existing CAR-T REMS programs. The experts recommended replacing manufacturer-created training with treatment center-administered programs, reporting standardized data points into a central repository, and allowing accrediting bodies to attest to quality and compliance. This research was peer-reviewed and published in Transplantation and Cellular Therapy.

Key Takeaways:

• The first 6 chimeric antigen receptor T cell (CAR-T) therapies approved in the United States have Risk Evaluation Mitigation Strategies (REMS) programs mandated by the FDA.
• The REMS programs aim to ensure the safe use of CAR-T therapy through timely recognition and management of unique severe risks and toxicities.
• The FDA has scaled back several features of existing CAR-T REMS programs redundant to standard clinical practice, including manufacturer-created training and data reporting to manufacturers.
• The seventh commercial CAR-T product, Aucatzyl, was the first approved without a REMS program as of November 8, 2024.
• Continued streamlining of CAR-T safety standards for existing and future approved CAR-T cells is required to maintain and increase access to effective adoptive cellular therapies.
• Researchers recommend replacing intensive manufacturer initial evaluation and ongoing REMS audits with accreditation by treatment centers and professional societies.

Statistics:

• 6: The number of CAR-T therapies with REMS programs mandated by the FDA.
• 70: The number of cellular therapy stakeholders who attended the ASTCT 80/20 Workshop.
• 2: The number of workshops convened by the ASTCT 80/20 Subcommittee to discuss CAR-T safety standards.
• 31(6): The issue and volume where the research was published.
• 2023: The year the researchers presented their findings at the ASTCT 80/20 Workshop.
• 2024: The year the seventh commercial CAR-T product, Aucatzyl, was approved without a REMS program.
• 17: The day of the month on which the news report was published (July 17, 2025).

Sources:

• NewsRx. Findings from Dana-Farber Cancer Institute in the Area of Immunologic Receptors Reported (Awakening From Rems: Astct 80/20 Ongoing Recommendations for Safe Use of Chimeric Antigen Receptor T Cells). FDA Law Weekly. July 17, 2025; p 292.
• Transplantation and Cellular Therapy. 2025;31(6).