Posted by Michael Wonder on 31 Aug 2017
FDA approves Genentech’s Actemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome
30 August 2017 - Actemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy.
Genentech announced today that the U.S. FDA has 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 patients two years of age and older. CRS, which is caused by an overactive immune response, has been identified as a potentially severe and life-threatening side effect of CAR T cell therapy for certain cancers.
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.
