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礼来制药获得欧洲加速审批的软组织癌症药物Lartruvo三期临床失败

2019-01-26 MedSci MedSci原创

软组织癌症联合用药多柔比星
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欧盟药品监管机构EMA表示，医生将停止向新患者开具礼来制药Lilly的软组织癌症药物Lartruvo，由于该药物未能通过原用以支持其2016年加速批准的3期试验。

欧盟药品监管机构EMA表示，医生将停止向新患者开具礼来制药Lilly的软组织癌症药物Lartruvo，由于该药物未能通过原用以支持其2016年加速批准的3期试验。

EMA在声明中表示：三期临床试验ANNOUNCE的初步结果显示，Lartruvo与多柔比星联合，并没有比单用多柔比星延长软组织癌患者的生命。虽然正在等待研究的全部结果，但EMA建议医生应停止用该药治疗新患者。

在ANNOUNCE中，Lartruvo联合多柔比星与单用多柔比星相比，总生存率几乎没有好转，20.4个月与19.7个月相比，这与统计学要求的显着性差异相差很远。无进展生存期（PFS），单用多柔比星为6.8个月，而联合用药仅为5.4个月。

这是EMA首次对已获得加速批准的产品终止其上市。与此同时，三期临床试验失败也影响了Lartruvo在美国的上市。

原始出处：


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  1. [GetPortalCommentsPageByObjectIdResponse(id=1991320, encodeId=fb5019913203b, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Tue Jul 09 09:49:00 CST 2019, time=2019-07-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=359470, encodeId=473d3594e0cd, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Mon Jan 28 22:27:28 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339158, encodeId=81a3133915815, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357093, encodeId=e43f135e09384, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1420430, encodeId=7f881420430c7, content=<a href='/topic/show?id=2221935219e' target=_blank style='color:#2F92EE;'>#软组织#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93521, encryptionId=2221935219e, topicName=软组织)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=52913579937, createdName=qilu_qi, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1569988, encodeId=70b0156998809, content=<a href='/topic/show?id=098ae147405' target=_blank style='color:#2F92EE;'>#癌症药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71474, encryptionId=098ae147405, topicName=癌症药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=69df15615030, createdName=surilei, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=)]
    2019-07-09 楚秀娟

    #三期临床#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1991320, encodeId=fb5019913203b, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Tue Jul 09 09:49:00 CST 2019, time=2019-07-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=359470, encodeId=473d3594e0cd, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Mon Jan 28 22:27:28 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339158, encodeId=81a3133915815, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357093, encodeId=e43f135e09384, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1420430, encodeId=7f881420430c7, content=<a href='/topic/show?id=2221935219e' target=_blank style='color:#2F92EE;'>#软组织#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93521, encryptionId=2221935219e, topicName=软组织)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=52913579937, createdName=qilu_qi, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1569988, encodeId=70b0156998809, content=<a href='/topic/show?id=098ae147405' target=_blank style='color:#2F92EE;'>#癌症药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71474, encryptionId=098ae147405, topicName=癌症药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=69df15615030, createdName=surilei, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=)]
    2019-01-28 orangesking

    好

    0

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    2019-01-28 ms9474365431325850

    #欧洲#

    0

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    2019-01-28 zhaojie88

    #ART#

    0

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    2019-01-28 qilu_qi

    #软组织#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1991320, encodeId=fb5019913203b, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Tue Jul 09 09:49:00 CST 2019, time=2019-07-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=359470, encodeId=473d3594e0cd, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0aa31415219, createdName=orangesking, createdTime=Mon Jan 28 22:27:28 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339158, encodeId=81a3133915815, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357093, encodeId=e43f135e09384, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1420430, encodeId=7f881420430c7, content=<a href='/topic/show?id=2221935219e' target=_blank style='color:#2F92EE;'>#软组织#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93521, encryptionId=2221935219e, topicName=软组织)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=52913579937, createdName=qilu_qi, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1569988, encodeId=70b0156998809, content=<a href='/topic/show?id=098ae147405' target=_blank style='color:#2F92EE;'>#癌症药物#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71474, encryptionId=098ae147405, topicName=癌症药物)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=69df15615030, createdName=surilei, createdTime=Mon Jan 28 09:49:00 CST 2019, time=2019-01-28, status=1, ipAttribution=)]
    2019-01-28 surilei

    #癌症药物#

    0