Kite Pharma : Yescarta Approved In Japan For Initial Treatment Relapsed Large B-Cell Lymphoma

Kite Pharma Inc., a Gilead Co. (GILD), and Daiichi Sankyo Co., Ltd. (DSKYF.PK) said that the Japan Ministry of Health, Labour and Welfare has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, for the initial treatment of patients with relapsed/refractory large B-cell lymphoma ( R/R LBCL): diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma.

The companies noted that Yescarta should be used only in patients who have not received prior transfusion of CAR T-cells targeted at CD19 antigen.

The approval of Yescarta for the initial treatment of R/R LBCL patients in Japan is based on clinical data, including the results of the global pivotal trial conducted by Kite (ZUMA-7).

In ZUMA-7 Study, patients with large B-cell lymphoma treated with yescarta in second-line achieved four-fold greater improvement in event-free survival of 8.3 months compared to two months for standard of care.

In ZUMA-7 study, patients treated with yescarta were 2.5 times more likely than standard of care to be alive at two years without disease progression or need for additional treatments.

Kite's manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to commence manufacturing Yescarta for the Japan market in 2023.

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