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美国授予诺华公司“Kisqali”“突破”地位

2018-01-03 MedSci MedSci原创

Kisqali

诺华公司的CDK4 / 6抑制剂Kisqali已经在美国获得了突破性的地位，作为一些乳腺癌患者的初始内分泌治疗。美国食品和药物管理局已批准激素受体阳性、人表皮生长因子受体- 2阴性(HR +/HER2 -)的绝经期或围绝经期晚期乳腺癌或转移性乳腺癌患者可使用他莫西芬或芳香化酶抑制剂联合治疗。此举是根据MONALEESA-7试验的数据得出的，诺华认为这是第一个完全致力于评估CDK4 / 6抑制剂治疗


诺华公司的CDK4 / 6抑制剂Kisqali已经在美国获得了突破性的地位，作为一些乳腺癌患者的初始内分泌治疗。

美国食品和药物管理局已批准激素受体阳性、人表皮生长因子受体- 2阴性(HR +/HER2 -)的绝经期或围绝经期晚期乳腺癌或转移性乳腺癌患者可使用他莫西芬或芳香化酶抑制剂联合治疗。
此举是根据MONALEESA-7试验的数据得出的，诺华认为这是第一个完全致力于评估CDK4 / 6抑制剂治疗（围）绝经期妇女HR + / HER2-晚期乳腺癌的III期试验。

根据数据显示，与单用内分泌治疗相比，Kisqali（ribociclib）联合他莫昔芬或芳香化酶抑制剂作为初始内分泌治疗可显着延长无进展生存期（PFS），结果分别为23.8个月和13.0个月。
绝经前乳腺癌是一种比绝经后乳腺癌更具侵袭性的疾病，是20-59岁女性癌症死亡的主要原因。
FDA的突破性指定是为了加速开发和审查治疗严重或危及生命的实验药物，当对至少一个临床重要终点的可用治疗的显着改善已经被证明的时候。

这种药在去年3月份在美国获得批准，与芳香化酶抑制剂联合使用，以治疗绝经后妇女的疾病，这一适应症也曾获得突破性进展。


此文系梅斯医学（MedSci)原创整理编译，转载需授权！

评论区 (3)
#插入话题
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    2018-08-24 yinhl1978

    #Kisqali#

    0

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    2018-01-05 nian.wang1982

    #诺华#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1931377, encodeId=542d19313e722, content=<a href='/topic/show?id=de6c10511e3' target=_blank style='color:#2F92EE;'>#Kisqali#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=74, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10511, encryptionId=de6c10511e3, topicName=Kisqali)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8217292, createdName=yinhl1978, createdTime=Fri Aug 24 22:21:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1282713, encodeId=4d731282e1317, content=<a href='/topic/show?id=2df29190553' target=_blank style='color:#2F92EE;'>#诺华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91905, encryptionId=2df29190553, topicName=诺华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6f63175, createdName=nian.wang1982, createdTime=Fri Jan 05 13:21:00 CST 2018, time=2018-01-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=275483, encodeId=3a262e5483b8, content=好资料学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=92191944782, createdName=thlabcde, createdTime=Thu Jan 04 21:15:30 CST 2018, time=2018-01-04, status=1, ipAttribution=)]
    2018-01-04 thlabcde

    好资料学习了!

    0

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