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Astellas的gilteritinib药物被评为孤儿药

2018-01-23 MedSci MedSci原创

Gilteritinib孤儿药
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Astellas实验性急性骨髓性白血病药物gilteritinib已被欧洲委员会授予孤儿药名称。这一决定表明，监管机构认为这种药物可能对罕见病患者有重大益处，其中每年在西欧确诊的新病例约有13，000例。Gilteritinib正在开发用于FLT3突变阳性复发或难治性AML的成人患者，这与特别不良的预后相关。最初通过与Kotobuki制药公司合作发现的药物目前正在III期试验中进行研究。Astel


Astellas实验性急性骨髓性白血病药物gilteritinib已被欧洲委员会授予孤儿药名称。

这一决定表明，监管机构认为这种药物可能对罕见病患者有重大益处，其中每年在西欧确诊的新病例约有13，000例。

Gilteritinib正在开发用于FLT3突变阳性复发或难治性AML的成人患者，这与特别不良的预后相关。
最初通过与Kotobuki制药公司合作发现的药物目前正在III期试验中进行研究。

Astellas肿瘤发展全球治疗领域负责人Steven Benner指出："我们非常感谢EMA承认罕见疾病患者的独特需求，并为gilteritinib在这些患者中的应用提供了一个潜在的支持途径。"

该药物在美国也有孤儿药地位。


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  1. [GetPortalCommentsPageByObjectIdResponse(id=1668991, encodeId=196a166899128, content=<a href='/topic/show?id=f1cf802378' target=_blank style='color:#2F92EE;'>#Gilteritinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8023, encryptionId=f1cf802378, topicName=Gilteritinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=651326488537, createdName=jml2018, createdTime=Fri Sep 21 22:26:00 CST 2018, time=2018-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1711353, encodeId=3bde1e11353b4, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Sep 24 01:26:00 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561950, encodeId=8963156195021, content=<a href='/topic/show?id=1f95289ea7' target=_blank style='color:#2F92EE;'>#Astellas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2897, encryptionId=1f95289ea7, topicName=Astellas)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Thu Jan 25 12:26:00 CST 2018, time=2018-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281588, encodeId=52c728158805, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a9d2256316, createdName=1217549fm29暂无昵称, createdTime=Wed Jan 24 13:11:11 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281484, encodeId=23e7281484ab, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a9d2256316, createdName=1217549fm29暂无昵称, createdTime=Wed Jan 24 07:37:18 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281395, encodeId=f4852813953d, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Tue Jan 23 23:25:04 CST 2018, time=2018-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281363, encodeId=770128136393, content=Astellas实验性急性骨髓性白血病药物gilteritinib已被欧洲委员会授予孤儿药名称., beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:29:17 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-09-21 jml2018

    #Gilteritinib#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1668991, encodeId=196a166899128, content=<a href='/topic/show?id=f1cf802378' target=_blank style='color:#2F92EE;'>#Gilteritinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8023, encryptionId=f1cf802378, topicName=Gilteritinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=651326488537, createdName=jml2018, createdTime=Fri Sep 21 22:26:00 CST 2018, time=2018-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1711353, encodeId=3bde1e11353b4, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Sep 24 01:26:00 CST 2018, time=2018-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561950, encodeId=8963156195021, content=<a href='/topic/show?id=1f95289ea7' target=_blank style='color:#2F92EE;'>#Astellas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2897, encryptionId=1f95289ea7, topicName=Astellas)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Thu Jan 25 12:26:00 CST 2018, time=2018-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281588, encodeId=52c728158805, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a9d2256316, createdName=1217549fm29暂无昵称, createdTime=Wed Jan 24 13:11:11 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281484, encodeId=23e7281484ab, content=henhao, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a9d2256316, createdName=1217549fm29暂无昵称, createdTime=Wed Jan 24 07:37:18 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281395, encodeId=f4852813953d, content=学习了.涨知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Tue Jan 23 23:25:04 CST 2018, time=2018-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=281363, encodeId=770128136393, content=Astellas实验性急性骨髓性白血病药物gilteritinib已被欧洲委员会授予孤儿药名称., beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Tue Jan 23 22:29:17 CST 2018, time=2018-01-23, status=1, ipAttribution=)]
    2018-09-24 zhaojie88

    #AST#

    0

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    2018-01-25 docwu2019

    #Astellas#

    0

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    2018-01-24 1217549fm29暂无昵称

    henhao

    0

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    2018-01-24 1217549fm29暂无昵称

    henhao

    0

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    2018-01-23 1ddf0692m34(暂无匿称)

    学习了.涨知识

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    2018-01-23 有备才能无患

    Astellas实验性急性骨髓性白血病药物gilteritinib已被欧洲委员会授予孤儿药名称.

    0

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