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.