FDA Expands Approval for Genentech’s Arthritis Drug

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Genentech’s Actemra (tocilizumab), a rheumatoid arthritis drug, has been approved for a new indication, treating CAR T cell-induced cytokine release syndrome (CRS), a side effect of CAR T cell therapy.

On Aug. 30, 2017, FDA approved a new indication for Actemra (tocilizumab), a rheumatoid arthritis drug by Genentech, a member of the Roche Group. FDA approved the drug for treating chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS). 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, according to Genentech.

“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 at Genentech, in a company press release. “Today's approval of Actemra for CRS provides physicians with an important tool to help manage this potentially life-threatening side effect.”

FDA granted priority review and orphan drug designation to Actemra for treating CAR T cell-induced CRS based on the rare, severe, and life-threatening nature of CRS and available data on the safety and efficacy of Actemra. FDA grants priority review designation to medicines that it has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious condition. Orphan drug designation may be granted to medicines intended for treating conditions that affect fewer than 200,000 people in the United States.


Actemra is a humanized interleukin-6 (IL-6) receptor antagonist approved for treating moderately to severely active rheumatoid arthritis. Actemra is also approved for treating giant cell arteritis. In addition, Actemra is also used as the intravenous formulation for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA), systemic juvenile idiopathic arthritis (SJIA), or CAR T cell-induced CRS.

Source: Genentech