Daiichi Sankyo (TYO: 4568) today announced the Japan Ministry of Health, Labor and Welfare (MHLW) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR)-T cell therapy, for the treatment of adult patients with certain relapsed/refractory large B-cell lymphomas.
The Japanese approval is for treatment of patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B cell lymphoma. The use of Yescarta is limited to patients not previously treated with a CD-19 CAR-positive T-cell infusion; patients previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant; and, patients not eligible for an autologous stem cell transplant.
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