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CHMP:Kisqali联合疗法扩展至所有HR + / HER2-局部晚期或转移性乳腺癌的女性

2018-11-19 MedSci MedSci原创

诺华公司近日宣布,欧洲药品管理局(EMA)的人用医药产品委员会(CHMP)采纳了积极的意见,建议扩大对Kisqali®(ribociclib)的适应症,这是一种CDK4 / 6抑制剂。CHMP推荐Kisqali与氟维司群联合用于治疗激素受体阳性 / 人类表皮生长因子受体-2阴性(HR + / HER2-)局部晚期或转移性乳腺癌患者。

诺华公司近日宣布,欧洲药品管理局(EMA)的人用医药产品委员会(CHMP)采纳了积极的意见,建议扩大对Kisqali®ribociclib)的适应症,这是一种CDK4 / 6抑制剂。CHMP推荐Kisqali与氟维司群联合用于治疗激素受体阳性 / 人类表皮生长因子受体-2阴性(HR + / HER2-)局部晚期或转移性乳腺癌患者。积极意见还建议批准Kisqali联合促黄体激素释放激素激动剂(LHRH)用于围绝经期前和围绝经期的女性。

诺华公司肿瘤学公司首席执行官Liz Barrett说:“CHMP意见使我们更接近于在欧洲为更多HR + / HER2-晚期乳腺癌患者提供治疗选择CHMP的这一积极意见是基于第三阶段MONALEESA-7MONALEESA-3试验的数据。MONALEESA III期试验招募了2000多名女性,这使得Kisqali成为迄今为止具有最广泛的一线临床试验证据的CDK4 / 6抑制剂。这些试验表明,与单独使用内分泌治疗相比,基于Kisqali的治疗方案可显著延长患者无进展生存期(PFS)。


原始出处:

http://www.firstwordpharma.com/node/1604998#axzz5XAXlsKfr

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    2019-01-28 yinhl1978
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    2019-04-19 luwei00
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1931378, encodeId=026519313e81e, content=<a href='/topic/show?id=de6c10511e3' target=_blank style='color:#2F92EE;'>#Kisqali#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10511, encryptionId=de6c10511e3, topicName=Kisqali)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, createdName=yinhl1978, createdTime=Mon Jan 28 12:37:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1646970, encodeId=890616469e094, content=<a href='/topic/show?id=0eb280e174e' target=_blank style='color:#2F92EE;'>#联合疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80717, encryptionId=0eb280e174e, topicName=联合疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2fce23370592, createdName=wincls, createdTime=Fri May 03 06:37:00 CST 2019, time=2019-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982512, encodeId=673719825121b, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Fri Apr 19 23:37:00 CST 2019, time=2019-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650746, encodeId=a9001650e4634, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Sat Jun 22 15:37:00 CST 2019, time=2019-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302662, encodeId=a8a1130266201, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Nov 21 05:37:00 CST 2018, time=2018-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386441, encodeId=4b04138644109, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Wed Nov 21 05:37:00 CST 2018, time=2018-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405876, encodeId=504714058e652, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Nov 21 05:37:00 CST 2018, time=2018-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353089, encodeId=d1ae353089e2, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Nov 19 20:28:55 CST 2018, time=2018-11-19, status=1, ipAttribution=)]
    2018-11-21 医生2394
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  7. [GetPortalCommentsPageByObjectIdResponse(id=1931378, encodeId=026519313e81e, content=<a href='/topic/show?id=de6c10511e3' target=_blank style='color:#2F92EE;'>#Kisqali#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10511, encryptionId=de6c10511e3, topicName=Kisqali)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, createdName=yinhl1978, createdTime=Mon Jan 28 12:37:00 CST 2019, time=2019-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1646970, encodeId=890616469e094, content=<a href='/topic/show?id=0eb280e174e' target=_blank style='color:#2F92EE;'>#联合疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80717, encryptionId=0eb280e174e, topicName=联合疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2fce23370592, createdName=wincls, createdTime=Fri May 03 06:37:00 CST 2019, time=2019-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1982512, encodeId=673719825121b, content=<a href='/topic/show?id=da628e19d5' target=_blank style='color:#2F92EE;'>#HER2-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=8719, encryptionId=da628e19d5, topicName=HER2-)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Fri Apr 19 23:37:00 CST 2019, time=2019-04-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650746, encodeId=a9001650e4634, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Sat Jun 22 15:37:00 CST 2019, time=2019-06-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302662, encodeId=a8a1130266201, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Wed Nov 21 05:37:00 CST 2018, time=2018-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386441, encodeId=4b04138644109, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Wed Nov 21 05:37:00 CST 2018, time=2018-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1405876, encodeId=504714058e652, content=<a href='/topic/show?id=a5404e589d7' target=_blank style='color:#2F92EE;'>#局部#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47589, encryptionId=a5404e589d7, topicName=局部)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d14c2562456, createdName=chg122, createdTime=Wed Nov 21 05:37:00 CST 2018, time=2018-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353089, encodeId=d1ae353089e2, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=82311653708, createdName=医者仁心5538, createdTime=Mon Nov 19 20:28:55 CST 2018, time=2018-11-19, status=1, ipAttribution=)]
    2018-11-21 chg122
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    2018-11-19 医者仁心5538

    学习了

    0

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