FDA drops REMS for CAR-T therapies

30 June 2025

The US Food and Drug Administration (FDA) has announced the elimination of the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies.

These products are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma.

This approach will potentially facilitate patient access to these treatments while continuing to prioritize safety

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