FDA eliminates risk evaluation and mitigation strategies (REMS) for autologous chimeric antigen receptor CAR T-cell immunotherapies

Last Updated: Wednesday, September 10, 2025

In June 2025, The U.S. Food and Drug Administration eliminated the Risk Evaluation and Mitigation Strategies for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T-cell immunotherapies. Doing so removes the requirements that hospitals and associated clinics that dispense these products must be specially certified and have on-site, immediate access to tocilizumab.

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FDA eliminates risk evaluation and mitigation strategies (REMS) for autologous chimeric antigen receptor CAR T-cell immunotherapies

U.S. Food and Drug Administration

FDA eliminates risk evaluation and mitigation strategies (REMS) for autologous chimeric antigen receptor CAR T-cell immunotherapies

Journal for ImmunoTherapy of Cancer

rhIL-7-hyFc, a long-acting interleukin-7, improves efficacy of CAR T-cell therapy in solid tumors

Nature Reviews Immunology

In vivo CAR engineering for immunotherapy

Seminars in Arthritis and Rheumatism

Advancing autoimmune rheumatic disease treatment: CAR T-cell therapies—evidence, safety, and future directions

Blood Advances

BCMA-directed CAR T-cell therapy in patients with multiple myeloma and CNS involvement

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Inequalities in CAR T-cell therapy access for US patients with relapsed/refractory DLBCL: A SEER-Medicare data analysis

Journal for ImmunoTherapy of Cancer

Novel PAP-targeted CAR-T therapy enhances antitumor efficacy through CoupledCAR approach

Stem Cells Translational Medicine

Anti-viral CD8 central memory veto cells as a new platform for CAR T cell therapy

Transplantation and Cellular Therapy

Neurotoxicity and rare adverse events in BCMA-directed CAR T cell therapy: A comprehensive analysis of real-world FAERS data

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