CHICAGO, IL / ACCESS Newswire / July 1, 2025 / The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation Strategies (REMS) requirements for currently approved B-cell maturation antigen (BCMA)- and CD19-directed autologous chimeric antigen receptor (CAR) T cell therapies. The American Society for Transplantation and Cellular Therapy (ASTCT) contributed to this policy change, in part, by a 2023 multidisciplinary workshop hosted by ASTCT's 80/20 Subcommittee of the Committee on Cellular Therapy.
The workshop convened approximately 70 stakeholders-including clinicians from leading academic centers, regulators, accrediting organizations, professional societies, and immune effector cell (IEC) therapy manufacturers-to evaluate whether the field's existing safety and quality workflows could satisfy REMS requirements. The overwhelming consensus: current infrastructure and practices, supported by education and collaboration, provide a robust foundation for the continued safe use of CAR T therapies. Professional society guidelines, central accrediting, and auditing bodies (eg, FACT, NMDP BioTherapiesSM among others), and transparent data repositories (eg, CIBMTR®) can be leveraged to help ensure safety and quality practices in the absence of REMS requirements.
The workshop findings were communicated directly to the FDA during the Cell Therapy Liaison Meeting, presented at multiple professional society meetings and public regulatory forums and published in the Transplantation and Cellular Therapy journal.
The FDA has determined that REMS programs are no longer necessary to ensure the benefits of these CAR T cell immunotherapies outweigh their risks. This decision acknowledges the hematology/oncology community's extensive experience in managing risks such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
The FDA concluded that the necessary safety information can be effectively conveyed through current product labeling-including boxed warnings-and Medication Guides, eliminating the need for separate REMS protocols that previously imposed operational burdens on treatment centers. In addition, time frames for monitoring following product administration were streamlined to make the clinical process more feasible for patients and families.
"We appreciate the FDA's decision recognizing the strength of our cell therapy community's clinical infrastructure. With elimination of the REMS requirements, we can reduce unnecessary administrative burden while maintaining the highest standards of patient safety. This will ultimately improve access to life-saving therapies" said Frederick L. Locke, MD, Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa FL, and Chair of the ASTCT Committee on Cellular Therapy."
"This announcement emphasizes the power of advocacy and collaboration between the FDA, accrediting bodies, professional societies and clinical sites in the cell therapy field." Sarah Nikiforow, MD, PhD, Cell Therapy Program at Dana-Farber Cancer Institute in Boston MA and cochair of the ASTCT 80/20 subcommittee.
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About The American Society for Transplantation and Cellular Therapy® (ASTCT®):
The American Society for Transplantation and Cellular Therapy (ASTCT) is an international professional society dedicated to improving the lives of blood and marrow transplant and cellular therapy patients. ASTCT represents more than 3,900 physicians, investigators and other health care professionals from more than 45 countries. We are dedicated to improving the application and success of blood and marrow transplantation and related cellular therapies.
Contact Information
Jayne Kramer
Marketing Manager
jkramer@astct.org
202.367.2313
SOURCE: American Society for Transplantation and Cellular Therapy
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