Roche Media Release: FDA approves Roche’s Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome Mittwoch, 30. August 2017 - 17:31
FDA approves Roche's Actemra/RoActemra (tocilizumab) for the treatment of CAR T cell-induced cytokine release syndrome | |
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| Actemra/RoActemra is the first FDA-approved treatment for severe or life-threatening cytokine release syndrome induced by CAR T cell therapy |
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| CAR T cell therapy is an immunotherapy designed for the treatment of certain cancers |
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| This is the seventh FDA approval for Actemra/RoActemra since its US launch in 2010 |
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Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Actemra/RoActemra® (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.
“Until today, there has never been an FDA-approved treatment to manage severe cytokine release syndrome associated with CAR T cell therapy, which is marked by a rapid onset and can cause life-threatening complications,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “Today's approval of Actemra/RoActemra for CRS provides physicians with an important tool to help manage this potentially life-threatening side effect.”
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