Genentech announced that the Food and Drug Administration (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 aged ≥2 years. This marks the first FDA-approved treatment for this indication.
The FDA approval was based on a retrospective analysis of pooled outcome data from clinical studies of CAR T cell therapies for blood cancers that evaluated Actemra for the treatment of CRS. Of the 45 patients treated with Actemra (with or without high-dose corticosteroids) for severe or life-threatening CRS, 31 (69%, 95% CI: 53–82%) achieved a response. Response was defined as CRS resolution within 14 days of the first dose, requiring no more than two doses and no drugs other than Actemra and corticosteroids. CRS resolution within 14 days was confirmed in a second study that involved an independent study population (n=15) with CAR T cell-induced CRS.
Actemra was previously granted Priority Review and Orphan Drug Designation for the treatment of CAR T cell-induced CRS by the FDA.
Actemra, a humanized interleukin (IL-6) receptor antagonist, is already approved to treat adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide adequate relief. In pediatric patients aged ≥2 years, intravenous Actemra is approved to treat active polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. In addition, the subcutaneous injection formulation is approved to treat adults with giant cell arteritis (GCA).
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