The FDA has reduced its Risk Evaluation and Mitigation Strategy reporting requirements for providers of chimeric antigen receptor T-cell therapies. This revision applies to six autologous CAR T-cell therapies, including four CD19-directed and two B-cell maturation antigen-directed agents. The FDA determined that the approved REMS for these products must be modified to minimize the burden on the healthcare delivery system. The modified REMS still requires providers to have at least two doses of tocilizumab on-site for each patient receiving CAR T cells. This change solidifies CAR T-cell therapies as a standard treatment and reduces administrative burden on clinicians providing the therapy.
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FDA reduces risk reporting for CAR T cells to ‘minimize the burden’ on providers
