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FDA NewsNewsworthy

Actemra First Treatment Approved for CAR T-Cell–Induced Cytokine-Release Syndrome

December 2017 Vol 3 No 6

On August 30, 2017, in association with the approval of the first CAR T-cell therapy (Kymriah), the FDA approved a new use for Actemra (tocilizumab; from Genentech), a humanized IL-6 receptor antagonist, for CAR T-cell–induced severe or life-threatening cytokine-release syndrome in patients older than 2. Cytokine-release syndrome can be caused by immune-cell therapy, such as CAR T-cell therapy.

This approval was based on a clinical trial showing the benefits of Actemra in patients with cytokine-release syndrome. Overall, 69% of patients had a response to Actemra within 14 days of treatment, meaning that the cytokine-release syndrome was resolved.

Serious side effects with Actemra include risk of serious infections and certain cancers, tears in the stomach, thrombocytopenia, neutropenia, hepatitis B infection, serious allergic reactions, and central nervous system problems.

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Last modified: January 2, 2018

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