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Daiichi Sankyo Seeks Yescarta Approval in Japan for Relapsed or Refractory B-cell Lymphoma
Daiichi Sankyo, one of the leading Japanese biopharmas specializing in cancer, holds exclusive rights in Japan for the development and production of Yescarta, the world’s second approved CAR-T drug. Given orphan drug designation by the Japanese government in 2018, Daiichi is now seeking approval of Yescarta for treating relapsed or refractory B-cell lymphoma.
Cancer therapies have evolved along with advances in technology and R&D innovations. One of them is the CAR-T [Chimeric antigen receptor (CAR) T-cell] therapy which is made by fusing specific antigen recognition sites to powerful immune cells. This new therapy has drawn the attention of oncologists and big pharmaceutical companies worldwide. However, the development and production of cell therapy drugs is anything but easy, leaving only two approved anti-CD19 CAR-T therapies available for treating certain types of blood cancers. One is Kymriah (tisagenlecleucel) from Novartis, and the other is Yescarta (axicabtagene ciloleucel) from Kite Pharma, a subsidiary of Gilead Sciences. Both treatments were approved in the US and Europe.
In 2017, Daiichi Sankyo entered into a strategic partnership with Kite Pharma to acquire exclusive rights to the development, manufacture, and sale of Yescarta in Japan. The treatment was then approved as an orphan drug in treating diffuse large B-cell lymphoma (DLBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), transformed follicular lymphoma (hereinafter TFL) and high-grade B-cell lymphoma (HGBL). Now based on the results of Kite’s global Phase 1/2 clinical study (ZUMA-1 study) and the results evaluating the efficacy of the drug in domestic phase II clinical trials, which is set be unveiled in academic events later, Daiichi Sankyo has filed a New Drug Application for the approval of Yescarta in treating relapsed or refractory B-cell lymphoma.
The approval of CAR-T therapy requires well-established regulations to ensure safety and effectiveness. Once Daiichi Sankyo acquires the approval, the patients with B-cell lymphoma who failed to respond to existing treatments would be provided with an authorized alternative. As the development of cell therapy grows, relevant regulations must follow as soon as possible to help those patients in need.
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