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CAR-T axicabtagene ciloleucel granted Orphan Drug designation for B-Cell Lymphoma by the Japan MHLW
By: News Feed | Last updated: 5th October 2018 | In: Haematology, ImmunoOncology, Immunotherapy, Medical News Asia, Oncology
Article Keywords
axicabtagene ciloleucel, B-cell lymphoma, CAR-CD19-T, CAR-T, CD19, Daiichi Sankyo, DLBCL, Gilead Sciences, HGBL, Kite Pharma, KTE-C19, lymphoma, NHL, non-Hodgkin, PMBCL, TFL, Yescarta
TOKYO and BASKING RIDGE, N.J., October 3, 2018 /PRNewswire/ — The Japan Ministry of Health, Labour and Welfare (MHLW) granted the Orphan Drug designation to axicabtagene ciloleucel (KTE-C19, Daiichi Sankyo) for the treatment of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBL), and transformed follicular lymphoma (TFL), which are all aggressive forms of non-Hodgkin lymphoma (NHL).
“Receiving Orphan Drug designation is an important step in expediting the development of axicabtagene ciloleucel in Japan and underscores the unmet needs of patients with these aggressive forms of relapsed or refractory B-cell lymphomas”
Kouichi Akahane, Head of Oncology Function, R&D Division, Daiichi Sankyo
Axicabtagene ciloleucel is a chimeric antigen receptor T-cell (CAR-T) therapy directed against CD19. The drug enables the patient’s innate immune system to eradicate certain types of B-cell lymphoma cells. Axicabtagene ciloleucel was previously approved in the United States (US) and Europe based on the results of the Phase 1/2 ZUMA-1 study. A similar design study to the ZUMA-1 is currently being planned in Japan.
Daiichi Sankyo obtained the exclusive development, manufacturing and commercialisation rights in Japan for axicabtagene ciloleucel from Kite Pharma, a Gilead company. In the US and Europe, the CAR-T therapy is marketed as Yescarta®.
The Orphan Drug designation system by the Japan MHLW is designed to promote research and support the development of therapies for severe and difficult-to-treat diseases affecting less than 50,000 Japanese patients, and for which a major unmet medical need.
References
Daiichi Sankyo. (2018, October 03) Japan MHLW Grants Orphan Drug Designation to Axicabtagene Ciloleucel for Treatment of Certain Types of B-Cell Lymphoma [Press Release]. Retrieved from https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006911.html
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