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CHMP对FLT3抑制剂Quizardinib治疗复发/难治性AML患者持负面意见

2019-10-20 Allan MedSci原创

QuizardinibCHMPFLT3抑制剂
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日本第一三共株式会社近日宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）对FLT3抑制剂Quizardinib的销售许可申请（MAA）持负面意见，Quizardinib预计用于治疗复发性/难治性FLT3-ITD成人急性髓细胞性白血病（AML）。

日本第一三共株式会社近日宣布，欧洲药品管理局（EMA）的人用药品委员会（CHMP）对FLT3抑制剂Quizardinib的销售许可申请（MAA）持负面意见，Quizardinib预计用于治疗复发性/难治性FLT3-ITD成人急性髓细胞性白血病（AML）。CHMP的意见是基于全球关键QuANTUM-R研究的最新数据，QuANTUM-R的结果已发表在《柳叶刀》杂志之上。

第一三共执行副总裁兼肿瘤学研究与开发全球负责人，医学博士Antoine Yver说：“尽管我们对这一观点感到失望，但我们将评估从CHMP收到的反馈，以确定Quizardinib治疗复发/难治性FLT3-ITD AML患者的下一步措施。尽管遭受了挫折，我们仍然相信Quizardinib对于FLT3-ITD AML患者具有潜在益处”。


原始出处：

http://www.firstwordpharma.com/node/1675046#axzz62qn99NTb

本文系梅斯医学（MedSci）原创编译整理，转载需授权!

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    2020-05-07 jklm09

    #抑制剂#

    0

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    2019-10-21 医生2394

    #CHMP#

    0

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    2019-10-21 freve

    #难治性#

    0

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    2019-10-21 fengyi816

    #FLT3#

    0

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    2019-10-21 szhvet

    #FLT3抑制剂#

    0