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Astellas 提供实验性AML疗法

2018-04-26 MedSci MedSci原创

AstellasAML疗法
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Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib，寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌。这种药物最初是通过与Kotobuki制药公司的研究合作发现的，已经在美国和欧盟确立了孤儿地位，这表明监管机构认为它有可能为罕见病患者带来显着益处。Astellas说，Gilteritinib是一种试验性化合物，它对内部双


Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib，寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌。

这种药物最初是通过与Kotobuki制药公司的研究合作发现的，已经在美国和欧盟确立了孤儿地位，这表明监管机构认为它有可能为罕见病患者带来显着益处。

Astellas说，Gilteritinib是一种试验性化合物，它对内部双链复制(ITD)和酪氨酸激酶域(TKD)有抑制作用，在AML患者中大约有1 / 3的患者出现FLT3突变。

这项药物也已经在日本提交批准，也是在第三阶段ADMIRAL试验的数据基础上提出的，这是一项针对FLT3突变成人患者的Gilteritinib与挽救性化疗的开放标签，多中心随机研究，这些患者为难治性或在一线AML治疗后复发的病人。

试验的共同主要终点是OS(总体生存)和CR(完全缓解)/ CRh(部分血液学恢复)率，研究仍在进行中。


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  1. [GetPortalCommentsPageByObjectIdResponse(id=2040719, encodeId=e8682040e19e2, content=<a href='/topic/show?id=5887461103d' target=_blank style='color:#2F92EE;'>#实验性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46110, encryptionId=5887461103d, topicName=实验性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c5e117, createdName=lujian, createdTime=Tue Mar 19 02:50:00 CST 2019, time=2019-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561952, encodeId=f5f8156195285, content=<a href='/topic/show?id=1f95289ea7' target=_blank style='color:#2F92EE;'>#Astellas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2897, encryptionId=1f95289ea7, topicName=Astellas)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Apr 28 13:50:00 CST 2018, time=2018-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1711463, encodeId=6d1a1e11463e3, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Mon Jul 23 15:50:00 CST 2018, time=2018-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=309569, encodeId=021730956911, content=Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib.寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌., 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=Thu Apr 26 23:06:45 CST 2018, time=2018-04-26, status=1, ipAttribution=)]
    2019-03-19 lujian

    #实验性#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2040719, encodeId=e8682040e19e2, content=<a href='/topic/show?id=5887461103d' target=_blank style='color:#2F92EE;'>#实验性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46110, encryptionId=5887461103d, topicName=实验性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c5e117, createdName=lujian, createdTime=Tue Mar 19 02:50:00 CST 2019, time=2019-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561952, encodeId=f5f8156195285, content=<a href='/topic/show?id=1f95289ea7' target=_blank style='color:#2F92EE;'>#Astellas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2897, encryptionId=1f95289ea7, topicName=Astellas)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Apr 28 13:50:00 CST 2018, time=2018-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1711463, encodeId=6d1a1e11463e3, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Mon Jul 23 15:50:00 CST 2018, time=2018-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=309569, encodeId=021730956911, content=Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib.寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌., 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=Thu Apr 26 23:06:45 CST 2018, time=2018-04-26, status=1, ipAttribution=)]
    2018-04-28 docwu2019

    #Astellas#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=2040719, encodeId=e8682040e19e2, content=<a href='/topic/show?id=5887461103d' target=_blank style='color:#2F92EE;'>#实验性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46110, encryptionId=5887461103d, topicName=实验性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c5e117, createdName=lujian, createdTime=Tue Mar 19 02:50:00 CST 2019, time=2019-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561952, encodeId=f5f8156195285, content=<a href='/topic/show?id=1f95289ea7' target=_blank style='color:#2F92EE;'>#Astellas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2897, encryptionId=1f95289ea7, topicName=Astellas)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Apr 28 13:50:00 CST 2018, time=2018-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1711463, encodeId=6d1a1e11463e3, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Mon Jul 23 15:50:00 CST 2018, time=2018-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=309569, encodeId=021730956911, content=Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib.寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌., 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=Thu Apr 26 23:06:45 CST 2018, time=2018-04-26, status=1, ipAttribution=)]
    2018-07-23 ms24272190615788285182

    #AST#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=2040719, encodeId=e8682040e19e2, content=<a href='/topic/show?id=5887461103d' target=_blank style='color:#2F92EE;'>#实验性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46110, encryptionId=5887461103d, topicName=实验性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3c5e117, createdName=lujian, createdTime=Tue Mar 19 02:50:00 CST 2019, time=2019-03-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1561952, encodeId=f5f8156195285, content=<a href='/topic/show?id=1f95289ea7' target=_blank style='color:#2F92EE;'>#Astellas#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2897, encryptionId=1f95289ea7, topicName=Astellas)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat Apr 28 13:50:00 CST 2018, time=2018-04-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1711463, encodeId=6d1a1e11463e3, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8b9831894722, createdName=ms24272190615788285182, createdTime=Mon Jul 23 15:50:00 CST 2018, time=2018-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=309569, encodeId=021730956911, content=Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib.寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌., 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=Thu Apr 26 23:06:45 CST 2018, time=2018-04-26, status=1, ipAttribution=)]
    2018-04-26 有备才能无患

    Astellas已经向美国监管机构提交了其实验性的急性髓系白血病(AML)治疗药物gilteritinib.寻求批准用于治疗FLT3突变阳性(FLT3mut+)复发或难治性的血癌.

    0