FOSTER CITY (dpa-AFX) - Daiichi Sankyo Co., Ltd. (DSKYF.PK) will transfer yescarta marketing authorization in Japan to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences Inc. (GILD), in 2023, the companies said in a statement.
Yescarta (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient's own immune system to fight cancer.
Kite Pharma., a Gilead Company, and Daiichi Sankyo announced the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta in Japan. Kite was acquired by Gilead Sciences later in 2017 after the Daiichi Sankyo partnership agreement.
Daiichi Sankyo and Kite have now agreed that the Marketing Authorization for Yescarta will be transferred to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc., in 2023. A Kite Cell Therapy Business Unit at Gilead Sciences K.K. will manage the sales and promotion activities of the product in Japan after the Marketing Authorization transfer.
Kite's manufacturing facility in El Segundo, California, U.S., has been approved by Japanese regulatory authorities to manufacture Yescarta for the Japanese market, and it is expected that supply will commence in early 2023. The first axicabtagene ciloleucel treatment center in Japan was authorized in December 2021.
Axicabtagene ciloleucel received Orphan Drug Designation from the Japan Ministry of Health, Labour, and Welfare in 2018 for the treatment of diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma and high-grade B-cell lymphoma. Yescarta was approved in Japan for the treatment of patients with relapsed or refractory large B-cell lymphomas, a type of non-Hodgkin lymphoma, in January 2021.
YESCARTA is approved in the U.S. and Europe for patients with certain types of relapsed or refractory B-cell lymphoma, where it is developed, manufactured and commercialized by Kite.
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