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安斯泰来的AML药物获FDA优先审查

2018-05-30 MedSci MedSci原创

安斯泰来的AML药物Gilteritinib
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Astellas Pharma的gilteritinib在美国被优先审查，为复发或难治性急性髓系白血病（AML）的FLT3突变的成人的治疗提供可能。由安斯泰来发现并与合作伙伴Kotobuki共同开发的这种药物，具有成为一线药物治疗的潜力。因为目前尚无批准用于治疗复发或难治性FLT3突变阳性（FLT3mut +）AML的FLT3靶向药物。"FLT3突变影响大约30％的AML患者，并且往往与较差的存活


Astellas Pharma的gilteritinib在美国被优先审查，为复发或难治性急性髓系白血病（AML）的FLT3突变的成人的治疗提供可能。

由安斯泰来发现并与合作伙伴Kotobuki共同开发的这种药物，具有成为一线药物治疗的潜力。因为目前尚无批准用于治疗复发或难治性FLT3突变阳性（FLT3mut +）AML的FLT3靶向药物。

"FLT3突变影响大约30％的AML患者，并且往往与较差的存活结果有关。许多患者在治疗后复发，或对现有治疗无效。简而言之，他们需要更多选择，"安斯泰来肿瘤发展高级副总裁兼全球治疗领域负责人Steven Benner说。

"FDA接受NDA的优先审查，是gilteritinib和Astellas在帮助AML患者和治疗他们的医生方面的一个重要里程碑。"

提交的资料包括来自III期ADMIRAL试验的数据，这是一项开放性，多中心，随机研究，在一线AML治疗后难治性或复发的FLT3突变的成人患者使用gilteritinib与挽救性化疗。

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

Gilteritinib在欧盟和美国都拥有孤儿地位。


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    2018-09-07 智智灵药

    #安斯泰来#

    0

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    2018-06-25 12498ca5m83暂无昵称

    #FDA优先审查#

    0

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    2018-06-01 yxch37

    #优先审查#

    0

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    2018-05-31 三生有幸9135

    学习一下谢谢分享

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=2060594, encodeId=78c8206059444, content=<a href='/topic/show?id=8a3b458198d' target=_blank style='color:#2F92EE;'>#安斯泰来#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45819, encryptionId=8a3b458198d, topicName=安斯泰来)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Sep 07 19:02:00 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2054956, encodeId=e179205495658, content=<a href='/topic/show?id=4e25e29816' target=_blank style='color:#2F92EE;'>#FDA优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7298, encryptionId=4e25e29816, topicName=FDA优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32a12500167, createdName=12498ca5m83暂无昵称, createdTime=Mon Jun 25 02:02:00 CST 2018, time=2018-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400126, encodeId=ec2514001269e, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Fri Jun 01 14:02:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320136, encodeId=61d932013677, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Thu May 31 05:54:21 CST 2018, time=2018-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320104, encodeId=00af320104ff, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Thu May 31 01:01:39 CST 2018, time=2018-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320091, encodeId=ad04320091d8, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Wed May 30 23:39:11 CST 2018, time=2018-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320086, encodeId=41f13200867f, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Wed May 30 23:34:53 CST 2018, time=2018-05-30, status=1, ipAttribution=)]
    2018-05-31 yfjms

    学习

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=2060594, encodeId=78c8206059444, content=<a href='/topic/show?id=8a3b458198d' target=_blank style='color:#2F92EE;'>#安斯泰来#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45819, encryptionId=8a3b458198d, topicName=安斯泰来)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Sep 07 19:02:00 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2054956, encodeId=e179205495658, content=<a href='/topic/show?id=4e25e29816' target=_blank style='color:#2F92EE;'>#FDA优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7298, encryptionId=4e25e29816, topicName=FDA优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32a12500167, createdName=12498ca5m83暂无昵称, createdTime=Mon Jun 25 02:02:00 CST 2018, time=2018-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400126, encodeId=ec2514001269e, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Fri Jun 01 14:02:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320136, encodeId=61d932013677, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Thu May 31 05:54:21 CST 2018, time=2018-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320104, encodeId=00af320104ff, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Thu May 31 01:01:39 CST 2018, time=2018-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320091, encodeId=ad04320091d8, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Wed May 30 23:39:11 CST 2018, time=2018-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320086, encodeId=41f13200867f, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Wed May 30 23:34:53 CST 2018, time=2018-05-30, status=1, ipAttribution=)]
    2018-05-30 orangesking

    好

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=2060594, encodeId=78c8206059444, content=<a href='/topic/show?id=8a3b458198d' target=_blank style='color:#2F92EE;'>#安斯泰来#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=45819, encryptionId=8a3b458198d, topicName=安斯泰来)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Fri Sep 07 19:02:00 CST 2018, time=2018-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2054956, encodeId=e179205495658, content=<a href='/topic/show?id=4e25e29816' target=_blank style='color:#2F92EE;'>#FDA优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7298, encryptionId=4e25e29816, topicName=FDA优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=32a12500167, createdName=12498ca5m83暂无昵称, createdTime=Mon Jun 25 02:02:00 CST 2018, time=2018-06-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400126, encodeId=ec2514001269e, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Fri Jun 01 14:02:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320136, encodeId=61d932013677, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=76, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Thu May 31 05:54:21 CST 2018, time=2018-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320104, encodeId=00af320104ff, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3da1990174, createdName=yfjms, createdTime=Thu May 31 01:01:39 CST 2018, time=2018-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320091, encodeId=ad04320091d8, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Wed May 30 23:39:11 CST 2018, time=2018-05-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320086, encodeId=41f13200867f, content=学习了.谢谢分享., beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/xkvRjYnJzzRJ2R0y7VhicibvkjPWHjIMmu4ZpKnE9cWAu4lVicS3uDUCfF4M4JWvrkrYfpb2KehPV0Ee29tPqyPEebBUibiaKhnvD/0, createdBy=f8412001184, createdName=惠映实验室, createdTime=Wed May 30 23:34:53 CST 2018, time=2018-05-30, status=1, ipAttribution=)]
    2018-05-30 惠映实验室

    学习了.谢谢分享.

    0

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