Chugai Pharmaceutical announced that the humanized anti-human IL-6 receptor monoclonal antibody "Actemra® for intravenous infusion 80 mg, 200 mg, 400 mg" : Tocilizumab (genetic recombination)] (hereinafter referred to as Actemra) was approved by the MHLW for an additional indication for "cytokine release syndrome associated with chimeric antigen receptor gene-introduced T cell infusion therapy". This application is based on results of Phase II international joint clinical trials that examined the effectiveness and safety of chimeric antigen receptor T cell medicine performed by Novartis. Cytokine release syndrome (CRS) is caused by the release of a large amounts of cytokines from cells along with an excessive immune reaction and a high rise in cytokine concentration in the blood. CRS is one of the side effects that is relatively common under CAR-T cell infusion therapy, and many patients present mild to moderate influenza-like symptoms (fever, nausea, chills, muscle pain, etc.). In some patients, however, severe hypotension, tachycardia, dyspnea, etc. are induced and the symptoms develop rapidly, leading to death.
Source: Chugai news release, May 29, 2018
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