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Shire胰腺癌药物Onivyde惨遭英国NICE拒绝!

2017-03-29 生物谷 生物谷

英国制药公司Shire的胰腺癌药物Onivyde近日在英国监管方面遭受挫折。英国NICE发布最终指南,拒绝将Onivyde用于英国国家服务系统(NHS)用于胰腺癌患者的治疗。具体而言,NICE拒绝批准Onivyde联合5-氟尿嘧啶(5-FU)及亚叶酸(LV)用于吉西他滨方案治疗后病情进展的转移性胰腺癌患者。在美国和欧盟,Oniv

 

英国制药公司Shire的胰腺癌药物Onivyde近日在英国监管方面遭受挫折。英国NICE发布最终指南,拒绝将Onivyde用于英国国家服务系统(NHS)用于胰腺癌患者的治疗。具体而言,NICE拒绝批准Onivyde联合5-氟尿嘧啶(5-FU)及亚叶酸(LV)用于吉西他滨方案治疗后病情进展的转移性胰腺癌患者。

在美国和欧盟,Onivyde分别于2015年11月和2016年10月获批,联合5-氟尿嘧啶(5-FU)和亚叶酸(LV)用于之前接受以吉西他滨为基础的方案治疗后病情进展的转移性胰腺癌成人患者。在临床试验中,与5-FU/LV方案相比,Onivyde/5-FU/LV方案使中位总生存期(OS)实现了统计学意义的显著延长(6.1个月 vs 4.2个月),达到了研究的主要终点。此外,Onivyde/5-FU/LV治疗组无进展生存期(PFS)显著延长,客观缓解率也高于对照组。安全性方面,最常见的3级及以上不良事件为中性粒细胞减少、疲倦、腹泻和呕吐,Onivyde/5-FU/LV治疗组发生率高于对照组5个百分点。

Onivyde是目前唯一一个显著延长既往接受过吉西他滨方案治疗的转移性胰腺癌患者生存期的药物,将为该群体提供一个非常重要的二线治疗选择。

但NICE得出结与论称,与当前临床实践方案奥沙利铂/5-FU/LV组合疗法相比,Onivyde/5-FU/LV组合疗法的中位总生存期(OS)基本一致。

另外,NICE表示,与5-FU/LV方案相比,Onivyde/5-FU/LV方案的成本效益增量比值(ICER)超过了10万英镑每个质量调整生命年(QALY),超出了常规NHS用药的治疗成本范围之内,因此不具有成本效益。

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  1. [GetPortalCommentsPageByObjectIdResponse(id=2036814, encodeId=0e80203681444, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Tue Apr 04 21:47:00 CST 2017, time=2017-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007866, encodeId=bb53200e86699, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Dec 31 21:47:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675163, encodeId=db4516e5163af, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Mon Jul 03 11:47:00 CST 2017, time=2017-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289011, encodeId=cdf21289011dc, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1521623, encodeId=49c1152162348, content=<a href='/topic/show?id=18bb8e08622' target=_blank style='color:#2F92EE;'>#英国NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87086, encryptionId=18bb8e08622, topicName=英国NICE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ce711379167, createdName=lvygwyt2785, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183836, encodeId=4bc118383667, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Thu Mar 30 18:59:02 CST 2017, time=2017-03-30, status=1, ipAttribution=)]
    2017-04-04 longerg
  2. [GetPortalCommentsPageByObjectIdResponse(id=2036814, encodeId=0e80203681444, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Tue Apr 04 21:47:00 CST 2017, time=2017-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007866, encodeId=bb53200e86699, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Dec 31 21:47:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675163, encodeId=db4516e5163af, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Mon Jul 03 11:47:00 CST 2017, time=2017-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289011, encodeId=cdf21289011dc, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1521623, encodeId=49c1152162348, content=<a href='/topic/show?id=18bb8e08622' target=_blank style='color:#2F92EE;'>#英国NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87086, encryptionId=18bb8e08622, topicName=英国NICE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ce711379167, createdName=lvygwyt2785, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183836, encodeId=4bc118383667, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Thu Mar 30 18:59:02 CST 2017, time=2017-03-30, status=1, ipAttribution=)]
    2017-12-31 tamgche
  3. [GetPortalCommentsPageByObjectIdResponse(id=2036814, encodeId=0e80203681444, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Tue Apr 04 21:47:00 CST 2017, time=2017-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007866, encodeId=bb53200e86699, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Dec 31 21:47:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675163, encodeId=db4516e5163af, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Mon Jul 03 11:47:00 CST 2017, time=2017-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289011, encodeId=cdf21289011dc, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1521623, encodeId=49c1152162348, content=<a href='/topic/show?id=18bb8e08622' target=_blank style='color:#2F92EE;'>#英国NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87086, encryptionId=18bb8e08622, topicName=英国NICE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ce711379167, createdName=lvygwyt2785, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183836, encodeId=4bc118383667, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Thu Mar 30 18:59:02 CST 2017, time=2017-03-30, status=1, ipAttribution=)]
    2017-07-03 liuli5088
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    2017-03-31 fusion
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  6. [GetPortalCommentsPageByObjectIdResponse(id=2036814, encodeId=0e80203681444, content=<a href='/topic/show?id=54f81338108' target=_blank style='color:#2F92EE;'>#Onivyde#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13381, encryptionId=54f81338108, topicName=Onivyde)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2f8f432, createdName=longerg, createdTime=Tue Apr 04 21:47:00 CST 2017, time=2017-04-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007866, encodeId=bb53200e86699, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Dec 31 21:47:00 CST 2017, time=2017-12-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1675163, encodeId=db4516e5163af, content=<a href='/topic/show?id=cb2116259ca' target=_blank style='color:#2F92EE;'>#Shire#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=85, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16259, encryptionId=cb2116259ca, topicName=Shire)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cdbc27169769, createdName=liuli5088, createdTime=Mon Jul 03 11:47:00 CST 2017, time=2017-07-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1289011, encodeId=cdf21289011dc, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1521623, encodeId=49c1152162348, content=<a href='/topic/show?id=18bb8e08622' target=_blank style='color:#2F92EE;'>#英国NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87086, encryptionId=18bb8e08622, topicName=英国NICE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6ce711379167, createdName=lvygwyt2785, createdTime=Fri Mar 31 12:47:00 CST 2017, time=2017-03-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=183836, encodeId=4bc118383667, content=谢谢分享,学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Thu Mar 30 18:59:02 CST 2017, time=2017-03-30, status=1, ipAttribution=)]
    2017-03-30 明月清辉

    谢谢分享,学习了

    0

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