{"id":765418,"date":"2023-06-22T08:33:53","date_gmt":"2023-06-22T12:33:53","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/kite-announces-completion-of-marketing-authorization-transfer-for-yescarta-car-t-cell-therapy-in-japan\/"},"modified":"2023-06-22T08:33:53","modified_gmt":"2023-06-22T12:33:53","slug":"kite-announces-completion-of-marketing-authorization-transfer-for-yescarta-car-t-cell-therapy-in-japan","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/kite-announces-completion-of-marketing-authorization-transfer-for-yescarta-car-t-cell-therapy-in-japan\/","title":{"rendered":"Kite Announces Completion of Marketing Authorization Transfer for Yescarta\u00ae CAR T-cell Therapy in Japan"},"content":{"rendered":"

<\/p>\n

Kite Announces Completion of Marketing Authorization Transfer for Yescarta\u00ae<\/sup> CAR T-cell Therapy in Japan<\/b><\/p>\n

— Gilead Sciences K.K. is Now Marketing Authorization Holder —<\/i><\/b><\/p>\n

— <\/i>Kite Cell Therapy Business Unit of Gilead Sciences K.K. will manage <\/i>the product\u2019s sales and promotion activities <\/i>—<\/i><\/b><\/p>\n

— Kite\u2019s Southern California Manufacturing Facility Supplying Yescarta <\/i>for the Japanese Market —<\/i><\/b><\/p>\n

SANTA MONICA, Calif.–(BUSINESS WIRE<\/a>)–
\nKite Pharma, Inc., a Gilead Company (Nasdaq: GILD), today announced that the Marketing Authorization in Japan for Yescarta\u00ae<\/sup> (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, has been transferred from Daiichi Sankyo Co., Ltd. to Gilead Sciences K.K., the Japan subsidiary of Gilead Sciences, Inc.<\/p>\n

\nThis follows the announcement<\/a> made by Daiichi Sankyo and Kite Pharma, Inc. in December 2022 about changes to their initial 2017 partnership whereby Daiichi Sankyo obtained the Marketing Authorization for Yescarta\u00ae<\/sup>. With this completion of the Marketing Authorization transfer, the sales and promotion activities of Yescarta\u00ae<\/sup> in Japan now will be managed by the Kite Cell Therapy Business Unit of Gilead Sciences K.K.<\/p>\n

\n\u201cAs the global leader in cell therapy, we appreciate the opportunity and responsibility of bringing this innovative treatment to as many eligible patients as possible who may benefit,\u201d said Cindy Perettie, Executive Vice President and Global Head of Kite. \u201cWe are pleased that we are able to fully leverage our manufacturing expertise and commercialization capabilities to meet increasing demand and maximize the potential of this important therapy for patients in Japan.\u201d<\/p>\n

\nThe first Yescarta\u00ae<\/sup> treatment center in Japan was authorized in December 2021, and there are now a total of six hospitals in Japan authorized to administer the therapy with many more anticipated by the end of the year. Kite\u2019s manufacturing facility in El Segundo, California, U.S. has been approved by Japanese regulatory authorities to manufacture Yescarta\u00ae<\/sup> for the Japanese market, and commenced its supply of the product earlier this year.<\/p>\n

\n\u201cWe are rapidly building a diverse pipeline in oncology, from antibody-drug conjugates and small molecules to cell therapy-based approaches,\u201d said Kennet Brysting, General Manager of Gilead Sciences K.K. \u201cWe look forward to advancing new treatments in oncology with the potential to positively impact the lives of people with cancer in Japan.\u201d<\/p>\n

About YESCARTA\u00ae<\/sup><\/b><\/p>\n

\nYescarta\u00ae<\/sup> (axicabtagene ciloleucel) is a CAR T-cell therapy directed against CD19 (a cell membrane protein), which harnesses a patient\u2019s own immune system to fight cancer. Axicabtagene ciloleucel is made by removing a patient\u2019s 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 into the patient\u2019s body. The CAR T-cell therapy is manufactured specifically for each patient and administered only once.<\/p>\n

\nAxicabtagene ciloleucel received Orphan Drug Designation<\/a> from the Japan Ministry of Health, Labour, and Welfare in 2018 for the treatment of diffuse large B-cell lymphoma (LBCL), 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 (R\/R) large B-cell lymphomas, a type of non-Hodgkin lymphoma, who are previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant, in January 2021. In December 2022, Yescarta was approved for the initial treatment of patients with R\/R LBCL in Japan.<\/p>\n

\nYescarta is approved in more than 20 countries, including the U.S., Canada, Europe, Great Britain, Switzerland, Brazil, Singapore, Israel, Japan, and Australia, for patients with certain types of relapsed or refractory B-cell lymphoma. It is developed and manufactured by Kite and commercialized by Kite in the U.S. and outside the U.S. by the respective Gilead affiliate.<\/p>\n

\nPlease see full U.S. Prescribing Information<\/a>, including BOXED WARNING<\/b> and Medication Guide.<\/p>\n

\nYescarta\u00ae<\/sup> is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:<\/p>\n