Advancing CAR T-Cell Therapy

This Viewpoint discusses the recent decision by the US Food and Drug Administration to eliminate Risk Evaluation and Mitigation Strategies requirements for chimeric antigen receptor (CAR) T-cell therapies for the treatment of cancer.

Corresponding Author: Upendra Mahat, MD, Division of Clinical Evaluation Hematology, Office of Clinical Evaluation, Center for Biologic Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Bldg 71, Room 6264, Silver Spring, MD 20993 (Upendra.mahat@fda.hhs.gov).

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