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.”

Chugai news release, May 29, 2018