On February 28, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed regulatory applications with the Ministry of Health, Labour and Welfare for the humanized anti-human IL-6 receptor monoclonal antibody, "Actemra Intravenous Infusion 80mg, 200mg, and 400mg" [generic name: tocilizumab (genetical recombination)] for the treatment of cytokine release syndrome induced by cancer treatment. This application is based on the clinical study results of an antineoplastic agent (Press release, Chugai, FEB 28, 2023, View Source [SID1234627922]).
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"We are very pleased to file for regulatory application of Actemra for the additional indication of cytokine release syndrome induced by cancer treatment in Japan," said Chugai’s President and CEO, Dr. Osamu Okuda. "Cytokine release syndrome, a common adverse reaction in CAR-T cell therapy and some antibody drugs, can be life-threatening in severe cases. We are closely working with the Japanese health authority to ensure that proper treatment is provided to patients on cancer therapies other than CAR-T cell therapy."
About Actemra
Actemra is the first therapeutic antibody created in Japan by Chugai. It is designed to block the activity of IL-6, a type of inflammatory cytokine. First launched in June 2005, the intravenous injection is approved for seven indications in Japan: Castleman’s disease, rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, cytokine release syndrome induced by tumor-specific T cell infusion therapy, adult Still’s disease, and SARS-CoV-2 pneumonia. In addition, Actemra subcutaneous injection is approved for three indications in Japan: rheumatoid arthritis, Takayasu arteritis, and giant cell arteritis. Actemra has obtained regulatory approval in more than 110 countries worldwide.