Daiichi Sankyo Company, Limited announced the Japan Ministry of Health, Labour 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. YESCARTA has been approved in Japan 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. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for YESCARTA in Japan from California-based Kite, a Gilead Company. The approval of YESCARTA in Japan is based on data from the global pivotal trial conducted by Kite (ZUMA-1) and results of a phase 2 study conducted by Daiichi Sankyo in Japan. In the Japanese phase 2, open-label, single-arm study, the same dose (2.0 x 106 cell/kg) of YESCARTA as used in the ZUMA-1 study was administered to assess efficacy and safety in 16 Japanese patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. An objective response rate, the primary endpoint of the study, was 86.7% (95% CI: 59.5 – 98.3%). The overall safety and tolerability profile of YESCARTA in the Japan trial was consistent with that observed in ZUMA-1. Dose limiting toxicity was not observed. Grade =3 treatment emergent adverse event occurred in all patients; most commonly neutropenia (81.3%), lymphopenia (81.3%) and thrombocytopenia (62.5%).Cytokine release syndrome, (CRS) a typical CAR T cell therapy-emergent adverse event, occurred in 13patients (81.3%, all grade), with grade =3 CRS in 1 patient (6.3%). Whereas neurological event, another typical CAR T cell therapy-emergent adverse event, was not observed.