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艾伯维白血病新药venetoclax斩获FDA第2个突破性药物资格

2016-01-24 MedSci MedSci原创

venetoclax艾伯维白血病
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由艾伯维（AbbVie）与罗氏（Roche）合作开发的一款抗癌药venetoclax近日在美国监管方面再传佳讯，FDA已授予venetoclax联合罗氏抗癌药美罗华（Rituxan，通用名：rituximab，利妥昔单抗）治疗复发性/难治性慢性淋巴细胞白血病（R/R CLL）的突破性药物资格。在一项涉及49例R/R CLL患者的Ib期临床研究中，venetoclax联合Rituxan使84

由艾伯维（AbbVie）与罗氏（Roche）合作开发的一款抗癌药venetoclax近日在美国监管方面再传佳讯，FDA已授予venetoclax联合罗氏抗癌药美罗华（Rituxan，通用名：rituximab，利妥昔单抗）治疗复发性/难治性慢性淋巴细胞白血病（R/R CLL）的突破性药物资格。在一项涉及49例R/R CLL患者的Ib期临床研究中，venetoclax联合Rituxan使84%（n=41/49）的患者实现缓解（肿瘤体积缩小），其中6例患者实现完全缓解（CR）或伴随不完全骨髓恢复的完全缓解（CRi）。

这也标志着venetoclax斩获的FDA第2个突破性药物资格。之前，FDA已于2015年4月授予venetoclax单药治疗携带17p删除突变（del 17p）的复发性/难治性慢性淋巴细胞白血病（R/R CLL）的突破性药物资格（报道：艾伯维治疗白血病新药venetoclax获FDA突破性药物认证）。本月初，FDA也已授予venetoclax单药治疗既往已接受至少一种疗法的CLL（包括del 17p CLL）的新药申请（NDA）优先审查资格，这也意味着venetoclax很有可能在今年夏天就能获批上市。在欧盟监管方面，欧洲药品管理局（EMA）已受理venetoclax单药治疗携带17p删除突变或TP53突变的慢性淋巴细胞白血病（CLL）的上市许可申请（MAA）。

venetoclax是一种B细胞淋巴瘤因子-2（BCL-2）抑制剂，BCL-2在细胞凋亡（程序性细胞死亡）中发挥重要作用，可阻止一些细胞（包括淋巴细胞）的凋亡，并且在某些类型癌症中过度表达，与耐药性的形成相关。venetoclax旨在选择性抑制BCL-2的功能，恢复细胞的通讯系统，让癌细胞自我毁灭，达到治疗肿瘤的目的。

目前，罗氏正与艾伯维开展一个大型临床项目，调查venetoclax单药及组合疗法治疗多种类型血癌，包括CLL、NHL、弥漫性大B细胞淋巴癌（DLBCL）、急性髓性白血病（AML）和多发性骨髓瘤（MM）。

venetoclax的成功对艾伯维尤其关键，该公司在去年3月以210亿美元从强生手中成功抢婚Pharmacyclics公司，顺利获得一款“钱”途无量且与自身肿瘤学管线完美互补的突破性抗癌药Imbruvica在美国市场的销售权。截至目前，Imbruvica在美国已收获4个适应症，在2015年度预计为艾伯维带来了10亿美元收入，该药将同时奠定艾伯维在高速增长的肿瘤治疗市场中的强大存在。业界预计Imbruvica的年销售峰值将突破50亿美元。艾伯维认为，venetoclax联合Imbruvica将创造血液癌症临床治疗的一个一流组合疗法。

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    2016-11-14 jingyanzhu715_39486101

    #药物资格#

    0

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    2016-09-21 canlab

    #NET#

    0

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    2016-05-17 yb6560

    #突破性药物#

    0

  4. 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    2016-06-12 jingyanzhu715_39486101

    #突破性药物资格#

    0

  5. 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    2016-01-27 李继凯

    厉害

    0

  6. 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    2016-01-27 李继凯

    希望

    0

  7. 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channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=96871613250, createdName=medcardio, createdTime=Sun Jan 24 11:55:00 CST 2016, time=2016-01-24, status=1, ipAttribution=)]
    2016-01-26 zhaojie88

    #艾伯维#

    0

  8. 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createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6KcicAVC1MwuK9CDibOwszLoEBg36ZXqzB5NDasNV9GTfFDmBicM1V8hUS4OtTicG3IiaFIKq4wqD23LUxORRJXqjVs/0, createdBy=00e81647535, createdName=I come, createdTime=Sun Jan 24 19:56:00 CST 2016, time=2016-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=58985, encodeId=bbdf58985f0, content=希望有基金会帮助有希望的孩子, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTK29w9r0upRgxUXHNhe7bd3VxHnhBSpibMbKOjtX92zXr78SkuZfUNuADrjHiaw6uibZaEYjh9cJLzew/132, createdBy=261e1682638, createdName=1de3b290m83(暂无匿称), createdTime=Sun Jan 24 13:50:00 CST 2016, time=2016-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=58959, encodeId=27b8589596d, content=新药价格昂贵，疗效虽然不错，但是还要进一步的研究，出来更多的需要以降低他的，价格, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=96871613250, createdName=medcardio, createdTime=Sun Jan 24 11:55:00 CST 2016, time=2016-01-24, status=1, ipAttribution=)]
    2016-01-24 I come

    白血病的希望

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1811327, encodeId=0d87181132eca, content=<a href='/topic/show?id=9a318e86937' target=_blank style='color:#2F92EE;'>#药物资格#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87869, encryptionId=9a318e86937, topicName=药物资格)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e3e72500135, createdName=jingyanzhu715_39486101, createdTime=Mon Nov 14 12:21:00 CST 2016, time=2016-11-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1733763, encodeId=3db21e33763b8, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, 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channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=96871613250, createdName=medcardio, createdTime=Sun Jan 24 11:55:00 CST 2016, time=2016-01-24, status=1, ipAttribution=)]
    2016-01-24 1de3b290m83(暂无匿称)

    希望有基金会帮助有希望的孩子

    0

  10. 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channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=96871613250, createdName=medcardio, createdTime=Sun Jan 24 11:55:00 CST 2016, time=2016-01-24, status=1, ipAttribution=)]
    2016-01-24 medcardio

    新药价格昂贵，疗效虽然不错，但是还要进一步的研究，出来更多的需要以降低他的，价格

    0

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