Genentech's Actemra receives approval from FDA to treat CRS patients

Roche Group member Genentech's drug Actemra (tocilizumab) has received approval from the U.S. Food and Drug Administration 

Actemra  is an intravenous injection that treats chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients 2 years of age and older.

“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,” Dr. Sandra Horning, Roche's chief medical officer and head of global product development, said in a statement. “Today's approval of Actemra for CRS provides physicians with an important tool to help manage this potentially life-threatening side effect.”

The approval comes after the FDA analyzed data from clinical trials of CAR T cell therapies for blood cancers. In the studies, Actemra was shown to have positive efficacy. 45 pediatric and adult patients were treated with Actemra, and 31 achieved a positive response. Additionally, no adverse reactions were reported.

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