On December 7, 2022 Kite Pharma, Inc., a Gilead Company, (hereafter Kite) and Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) jointly reported the revision of their 2017 partnership agreement, which gave Daiichi Sankyo exclusive rights to develop, manufacture and commercialize Yescarta (axicabtagene ciloleucel) in Japan (Press release, Kite Pharma, DEC 7, 2022, https://www.businesswire.com/news/home/20221207005859/en/Kite-and-Daiichi-Sankyo-Announce-Changes-to-YESCARTA%C2%AE-CAR-T-Cell-Therapy-Licensing-Agreement-in-Japan [SID1234624918]). Kite was acquired by Gilead Sciences, Inc. 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.

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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, and there are now six hospitals in Japan authorized to administer the therapy.

"We are confident that these changes will benefit patients in Japan by increasing capacity and support broader patient access to this important treatment for blood cancer patients and we remain committed to working together with Kite to ensure a smooth transfer during this transitional period," said Shoji Hirashima, Senior Executive Officer, Head of Japan Business Unit of Daiichi Sankyo.

"As the global leader in cell therapy, we are pleased that our partnership with Daiichi Sankyo has brought this innovative therapy to patients in Japan. We look forward to building on the momentum to accelerate efforts in Japan to maximize access and impact for patients as part of Gilead and Kite’s expansion into oncology in Japan," said Christi Shaw, CEO of Kite.

About YESCARTA

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. Axicabtagene ciloleucel is made by removing a patient’s T cells from their blood and engineering them in the lab to express chimeric antigen receptors so that they can recognize and destroy cancer cells when they are infused back to the patient’s body. The CAR T therapy is manufactured specifically for each patient and administered only once. 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 lymphomas1, a type of non-Hodgkin lymphoma, in January 2021. Japan has the second-largest number of people diagnosed with non-Hodgkin lymphoma globally2.

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.

Please see full U.S. Prescribing Information, including BOXED WARNING and Medication Guide.

Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. (1.1)
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. (1.1)

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1.2)
For the full European Prescribing Information, please visit: View Source