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Home » FDA Relaxes CAR-T Cell REMS During Ongoing Tocilizumab Shortage
FDA Relaxes CAR-T Cell REMS During Ongoing Tocilizumab Shortage
December 15, 2021
The FDA’s Center for Biologics Evaluation and Research has issued a temporary policy guidance addressing the COVID-19-related shortage of Roche’s blockbuster immunosuppressive tocilizumab, which the FDA requires to be on hand during infusions of chimeric antigen receptor (CAR-T) cell immunotherapies as cancer treatments.
Due to the potential for severe or even life-threatening cytokine release syndrome after these infusions, the FDA initially mandated that a minimum of two doses of tocilizumab — a monoclonal antibody against the interleukin-6 receptor — be nearby to be administered within two hours if needed. Tocilizumab, known as Actemra in the U.S., inhibits the body's inflammatory reaction to the immunotherapy.
The FDA said it doesn't intend to take enforcement action against sponsors or healthcare providers with respect to the risk evaluation and mitigation strategy (REMS) that requires them to have two doses of tocilizumab on hand for CAR-T cell infusion patients.
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