ASTCT News
Published on July 01, 2025
Advocacy Alert: FDA Eliminate REMS for BCMA- and CD19-Directed Autologous CAR T Cell Immunotherapies
by ASTCT Advocacy Update
The U.S. Food and Drug Administration (FDA) has announced that Risk Evaluation and Mitigation Strategies (REMS) will no longer be required for BCMA- and CD19-directed autologous CAR T cell therapies. This decision follows an assessment that existing clinical experience and established management protocols are sufficient to ensure the safe use of these therapies.
ASTCT informed this decision via advocacy by our 80/20 Subcommittee of the Committee on Cellular Therapy. In June 2023, ASTCT convened a workshop of more than 70 stakeholders—clinicians, regulators, accrediting bodies, and manufacturers—to assess whether existing safety and quality workflows satisfy the intentions of FDA-mandated REMS programs.
The consensus: with robust clinical infrastructure, education, and collaboration, REMS can be removed without compromising patient safety. 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. These findings were presented to the FDA, shared across professional forums and published in the Transplantation and Cellular Therapy journal.
The FDA has determined that REMS 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) and should improve patient access to these therapies.
Hear from Frederick L. Locke, MD, Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy and Sarah Nikiforow, MD, PhD, cochair of the ASTCT 80/20 subcommittee about this announcement.
Read more about the FDA’s decision.
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