FDA Approves Genentech’s Actemra for Treatment of CAR-T Cell-Induced Cytokine Release Syndrome

  • August 31, 2017

The FDA approved Actemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older. The Genentech press release including Important Safety Information is linked here, and an FDA press release announcing the Actemra approval as part of its CAR T cell therapy approval is linked here.

– CRS, which is caused by an overactive immune response, has been identified as a side effect of CAR T cell therapy for certain cancers. Severe cases can lead to potentially life-threatening complications such as cardiac dysfunction, acute respiratory distress syndrome or multi-organ failure.

– The approval is based on a retrospective analysis of pooled outcome data from clinical trials of CAR T cell therapies for blood cancers, which assessed the efficacy of Actemra in the treatment of CRS.

-This marks the seventh FDA approval for Actemra since its U.S. launch in 2010.

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