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消息!拜耳抗癌药Stivarga肝细胞癌III期临床大获成功

2016-05-09 生物谷 生物谷

  拜耳抗癌药Stivarga近日在关键III期临床试验中获得积极数据,有望将肝细胞癌列入适应症名单。Stivarga是一种口服的多激酶抑制剂,能够抑制肿瘤发生发展中VEGFR 1-3、KIT、RET、PDGFR及FGFR等多种重要激酶的活性,目前已经在多个肿瘤中获批。 这项名为RESORCE的III期临床试验数据表明,Stivarga (regorafenib)能够显着

 

拜耳抗癌药Stivarga近日在关键III期临床试验中获得积极数据,有望将肝细胞癌列入适应症名单。Stivarga是一种口服的多激酶抑制剂,能够抑制肿瘤发生发展中VEGFR 1-3、KIT、RET、PDGFR及FGFR等多种重要激酶的活性,目前已经在多个肿瘤中获批。

这项名为RESORCE的III期临床试验数据表明,Stivarga (regorafenib)能够显着延长不可手术及既往接受过多吉美(索拉菲尼)治疗却继续恶化的肝细胞癌患者的总生存期。多吉美(索拉菲尼)也是拜耳研发并上市的抗癌药,已经在肝癌中获批。

Stivarga目前已经在结直肠癌、胃肠道间质瘤中获批,本应是一个销量很好的药物,然而由于美国市场上抗癌药竞争异常激烈,今年第一季度Stivarga的销售额反而降低了24%。今年第一季度,Stivarga的整体销售额为6700万欧元,比去年减少了4000万欧元,如果能够在肝细胞癌中获批,对Stivarga的市场份额将会起到积极的推动作用。

同时,接下来的几个月,拜耳将努力寻求机会推进该药物在德国的上市工作,毕竟德国是欧洲最大的市场。

拜耳制药部门负责人Joerg Moeller表示,目前肝细胞癌仍然缺乏有效的治疗手段,Stivarga有望成为继索拉菲尼之后第二个系统性治疗肝细胞癌的靶向药物。多吉美(索拉菲尼)是一种口服多靶向性的抗癌药,目前已经在肝癌、肾癌、甲状腺癌等适应症中获批。多吉美(索拉菲尼)目前的销量依旧增长迅速,第一季度销售额同比增加了10%,达到了2.13亿欧元。多吉美(索拉菲尼)也是迄今为止唯一一个被FDA批准的系统性治疗肝细胞癌的靶向药。

肝细胞癌预后很差,尽管目前治疗手段在不断进步,患者的平均总生存期仍然只有7至11个月。拜耳表示,将在今年年底之前提交这项名为RESORCE的III期临床试验数据,作为Stivarga上市申请的重要依据,用于治疗不可手术的肝细胞癌患者。

肝细胞癌是最常见的肝癌类型,全世界肝癌病例中,大约70-85%为肝细胞癌。肝癌是世界第六大常见癌症,也是第二大致死癌症类型。中国为肝细胞癌高发国家,目前仍缺乏有效的药物,如果Stivarga获批,将有望造福这部分癌症患者。

原始出处:

Bayer eyes liver cancer indication for Stivarga

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    2016-08-01 xjy02
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[GetPortalCommentsPageByObjectIdResponse(id=1652751, encodeId=c2ed1652e5191, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Mon Jun 27 06:04:00 CST 2016, time=2016-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1863242, encodeId=23591863242b8, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1652751, encodeId=c2ed1652e5191, content=<a href='/topic/show?id=5b011018e07' target=_blank style='color:#2F92EE;'>#I期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=75, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10187, encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Mon Jun 27 06:04:00 CST 2016, time=2016-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1863242, encodeId=23591863242b8, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=102, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85318, encodeId=de4485318b9, content=值得阅读,学习!, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRuUXgacXpPeW0x8Z3Qr9c3I2kTic4ZIpR29iaftYgkjRcbv982icYMtqANBPYBgPnOia6mVtX76qMXuc/0, createdBy=ebe61630855, createdName=1dd8a7c5m95(暂无匿称), createdTime=Tue May 10 12:47:00 CST 2016, time=2016-05-10, status=1, ipAttribution=)]
    2016-05-10 juliusluan78
  6. 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    2016-05-11 sunylz
  7. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=85318, encodeId=de4485318b9, content=值得阅读,学习!, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mStl88fu4NfNLvzZhgPxRuUXgacXpPeW0x8Z3Qr9c3I2kTic4ZIpR29iaftYgkjRcbv982icYMtqANBPYBgPnOia6mVtX76qMXuc/0, createdBy=ebe61630855, createdName=1dd8a7c5m95(暂无匿称), createdTime=Tue May 10 12:47:00 CST 2016, time=2016-05-10, status=1, ipAttribution=)]
    2016-05-11 ying_wu
  8. 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  9. 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    2016-05-10 1dd8a7c5m95(暂无匿称)

    值得阅读,学习!

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