Kite says Yescarta now approved in Japan for initial treatment

Kite Pharma, Inc., a Gilead (GILD) company, and Daiichi Sankyo (DSNKY) jointly announced that the Japan Ministry of Health, Labour and Welfare has approved Yescarta, a chimeric antigen receptor T-cell therapy, for the initial treatment of patients with relapsed/refractory large B-cell lymphoma: diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma. Yescarta should be used only in patients who have not received prior transfusion of CAR T-cells targeted at CD19 antigen. The Standard of Care to treat LBCL patients has historically been a multi-step process that starts with chemoimmunotherapy, followed by high-dose chemotherapy and then ends with a stem cell transplant. Although approximately 60% of newly diagnosed LBCL patients will respond to the initial treatment with chemotherapy, 40% will relapse or will not respond and need second-line treatment. Yescarta is now approved for the initial treatment of R/R LBCL patients in Japan.