US immunotherapy specialist Kite Pharma, Inc. has announced that the Marketing Authorization for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. (TYO: 4568) to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc (NASDAQ: GILD).
History of Yescarta and Licensing Deal
Yescarta, originated by Kite Pharma, was obtained by Daiichi Sankyo via a licensing deal in January 2017, which later became part of Gilead’s portfolio when it acquired Kite in August. The drug received approval for marketing in the US in October 2017 for use in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) who have previously received two or more kinds of systematic therapies, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and DLBCL (transformed FL) derived from follicular lymphoma (FL).
Yescarta’s Market Approvals in China and Japan
In China, Yescarta, developed by Fosun Kite Biotechnology Co., Ltd, a joint venture between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Kite Pharma, obtained market approvals to treat adult patients with relapsed or refractory large B-cell lymphoma after second-line or above systemic therapy, including various forms of lymphoma. In Japan, Yescarta was approved for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphomas, a type of non-Hodgkin lymphoma, in January 2021. In December 2022, Yescarta was approved for the initial treatment of patients with R/R LBCL in Japan, with 6 hospitals approved to carry out individualized treatments.
Return of Marketing Rights and Focus on ADCs
Daiichi Sankyo announced the return of marketing rights to Kite in relation to the drug in December last year, as its focus shifted towards antibody drug conjugates (ADCs). This transfer marks a strategic move in the distribution and marketing of Yescarta, highlighting the evolving landscape of immunotherapy treatments in Japan.-Fineline Info & Tech
