Photo courtesy of Roche
Tocilizumab (Actemra®)
The US Food and Drug Administration (FDA) has approved tocilizumab (Actemra®) for the treatment of patients age 2 and older who have severe or life-threatening cytokine release syndrome (CRS) induced by chimeric antigen receptor (CAR) T-cell therapy.
Tocilizumab is a humanized interleukin-6 receptor antagonist.
The drug is also FDA-approved to treat adults with rheumatoid arthritis or giant cell arteritis and patients age 2 and older with polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis.
The full prescribing information for tocilizumab, which includes a boxed warning about the risk of serious infections, is available at http://www.actemra.com. The drug is jointly developed by Genentech (a member of the Roche Group) and Chugai Pharmaceutical Co.
The FDA’s latest approval of tocilizumab coincided with the FDA’s approval of the CAR T-cell therapy tisagenlecleucel (Kymriah, formerly CTL019) to treat pediatric and young adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
According to Genentech, the FDA’s decision to expand the approval of tocilizumab is based on a retrospective analysis of pooled outcome data from clinical trials of CAR T-cell therapies in patients with hematologic malignancies.
For this analysis, researchers assessed 45 pediatric and adult patients treated with tocilizumab, with or without additional high-dose corticosteroids, for severe or life-threatening CRS.
Thirty-one patients (69%) achieved a response, defined as resolution of CRS within 14 days of the first dose of tocilizumab.
No more than 2 doses of tocilizumab were needed, and no drugs other than tocilizumab and corticosteroids were used for treatment.
No adverse reactions related to tocilizumab were reported.
