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YESCARTA approved in Japan for treatment of relapsed and difficult-to-treat large B-cell lymphoma (DLBCL)

 Last Update: 2021-02-01
 Source: Internet
 Author: User

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Japan's Ministry of Health, Labour and Industry (MHLW) has approved the embedded antigen-subject (CAR) T-cell therapy YESCARTA® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed and difficult-to-treat large B-cell lymphoma (DLBCL), the company announced today.
currently, YESCARTA® has been approved in Japan for the treatment of recurring and difficult-to-treat large B-cell lymphoma, primary vertical B-cell lymphoma, transformed folytic lymphoma, or high-level B-cell lymphoma.
YESCARTA is limited to patients who have not previously received CD-19 CAR-T cell infusion therapy;
January 2017, the company obtained a license from Gilead corporation to develop, manufacture and commercialize THECARTA ® (axicabtagene ciloleucel) exclusively in Japan.
approval is based on data from ZUMA-1's global key trials and the latest results from the second phase of the Japan Phase III study.
the same dose (2.0 x 106 cells/kg) used in the ZUMA-1 study in the Phase II Open Single Arm Study in Japan.
objective mitigation rate was the main endpoint of the study, at 86.7 per cent (95 per cent CI: 59.5 - 98.3 per cent).

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