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Daiichi Sankyo and Kite’s Yescarta (Axicabtagene Ciloleucel) CAR T-Cell Therapy Receives MHRA’s Approval for the Treatment of Lymphoma in Japan

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Daiichi Sankyo and Kite’s Yescarta (Axicabtagene Ciloleucel) CAR T-Cell Therapy Receives MHRA’s Approval for the Treatment of Lymphoma in Japan

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  • The approval is based on the (ZUMA-1) & P-II study of axicabtagene ciloleucel. In a P-II study, the same dose of axicabtagene ciloleucel (2.0 x 106 cells/kg) was given as in (ZUMA-1) study in 16 patients with r/r large B-cell lymphoma including DLBCL, PMBCL, t-FL & high-grade B-cell lymphoma
  • The results showed an ORR (86.7%), overall safety & tolerability profile was consistent with ZUMA-1 & no DLT was observed
  • Yescarta is approved in the US & EU for multiple types of r/r B-cell lymphoma that is developed, manufactured & commercialized by Kite. Upon collaboration in Jan 2017, both companies will also sign an exclusive license agreement to commercialize axicabtagene ciloleucel in Japan

Ref: Gilead | Image: Daiichi Sankyo

Click here to­ read the full press release 

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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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