FDA Modifies REMS Requirements for CAR T Cell Therapies; ASTCT Thanks 80/20 Task Force for Advocacy
On June 26, 2024, the United States Food and Drug Administration (FDA) announced modifications to Risk Evaluation and Mitigation Strategies (REMS) for Chimeric Antigen Receptor (CAR) T cell therapies to reduce the burden on the healthcare system without compromising patient safety. Several commercially approved CAR T cell therapies are under REMS programs due to the risks of cytokine release syndrome (CRS) and neurological toxicities.
The 80/20 Task Force of the American Society for Transplantation and Cellular Therapy (ASTCT) has advocated for reduced REMS requirements due to the cumulative expertise and enhanced quality processes, including requirements in the FACT Standards. ASTCT conveyed its thanks to the task force, including co-chairs Fred Locke and Sarah Nikiforow, for their efforts.
Under the modified REMS programs, risks can be conveyed through current product labeling, including a boxed warning and Medication Guides, and previously required educational and training materials were thereby found to be redundant. Reporting of adverse events suggestive of CRS or neurological toxicities are also removed due to their redundancies with routine safety monitoring.
A REMS requirement that remains, however, is that hospitals and clinics dispensing CAR T cell therapies must have immediate access to a minimum of two doses of tocilizumab for each patient prior to infusion.
To continue protecting patient safety following CAR T cell therapy, compliance with FACT Standards for provider qualifications, education, and training; quality systems; and therapy administration are critical. We applaud all Immune Effector Cell Therapy programs for voluntarily complying with these rigorous standards to provide safe and effective therapies.
