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NICE改变了对辉瑞公司Besponsa的看法

2018-08-09 MedSci MedSci原创

辉瑞公司Besponsa
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英国国家健康保险协会(NICE)已经撤销了拒绝辉瑞公司(Pfizer)的Besponsa (inotuzumab ozogamicin)作为一种治疗成人白血病的药物的决定草案，这意味着该药物将在英格兰和威尔士的NHS(英国国家医疗服务体系)中使用。此举是继辉瑞公司成功呼吁该研究所拒绝将Besponsa作为治疗成人复发或难治性CD22阳性B细胞前体急性淋巴细胞白血病（ALL）的决定。Besponsa



英国国家健康保险协会(NICE)已经撤销了拒绝辉瑞公司(Pfizer)的Besponsa (inotuzumab ozogamicin)作为一种治疗成人白血病的药物的决定草案，这意味着该药物将在英格兰和威尔士的NHS(英国国家医疗服务体系)中使用。

此举是继辉瑞公司成功呼吁该研究所拒绝将Besponsa作为治疗成人复发或难治性CD22阳性B细胞前体急性淋巴细胞白血病（ALL）的决定。

Besponsa是一种抗体药物偶联物，由靶向CD22的单克隆抗体组成，CD22是在约90％的B细胞恶性肿瘤上表达的细胞表面抗原，与细胞毒性有关。

当药物与恶性B细胞上的CD22结合时，将其带入细胞，释放细胞毒性剂卡奇霉素以破坏它。

INO-VATE试验的数据显示，在326名复发或难治性cd22阳性的成人患者中，该药物与标准的护理化疗进行了比较，结果显示，该疗法的完全缓解率增加了一倍以上。

然而，在去年6月发布的指南草案中，该研究所认为临床试验的证据表明，与目前的治疗方法相比，Besponsa没有生存获益，但确实注意到更多接受该药治疗的人随后能够产生干细胞。 与标准治疗相比，移植并进入缓解期。

ALL是一种侵袭性白血病，需求高，预后差。目前的标准治疗是强化，长期化疗，但目前只有10％的ALL患者在一线治疗后复发可存活5年或更长时间。

"我们对NICE的决定表示欢迎，并且很高兴全国的白血病患者现在可以常规使用这种可能具有革命性的治疗方案，"英国辉瑞公司肿瘤科主管Craig Eagle博士说。"我们特别感谢临床和患者团体社区，他们也在整个过程中不知疲倦地工作，以确保可以从inotuzumab ozogamicin中受益的患者获得它。"

布里斯托尔IBD%E8%AF%8A%E6%B2%BB%E8%BF%87%E7%A8%8B%E4%B8%AD%E7%9A%84%E8%AF%84%E4%BC%B0-Part%202" target="_blank">血液学和肿瘤学中心的David Marks教授补充说："今天的宣布对于全国已被诊断患有此类复发或难治性急性淋巴细胞白血病的患者来说是个好消息。Inotuzumab ozogamicin可以为患者提供生路，让他们有机会完全缓解并有资格进行潜在的治疗性异基因干细胞移植。

经过IBD%E8%AF%8A%E6%B2%BB%E8%BF%87%E7%A8%8B%E4%B8%AD%E7%9A%84%E8%AF%84%E4%BC%B0-Part%202" target="_blank">血液学界几个月的不懈努力，这种药物现在可以通过英国国民健康保险制度(NHS)正常使用。因此，对于符合条件的患者及其家属来说，这将是一个可喜的解脱。


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  1. [GetPortalCommentsPageByObjectIdResponse(id=1289029, encodeId=62c31289029f8, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Sat Aug 11 12:50:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337575, encodeId=6e4433e5756d, content=^_^^_^^_^, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Swp2ehfHpiciczeTntUyQOlIGMzQ705ic67sdMTVMbwTv7KbmlUvxrGvRSvQZjPkz7ib5tEDfIaORgczPtmHDpwojg/0, createdBy=c54b2163125, createdName=wqkm, createdTime=Thu Aug 09 22:28:05 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337574, encodeId=8da333e574f3, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Thu Aug 09 22:22:39 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337572, encodeId=4bff33e57276, content=不错的文章值得拥有哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Thu Aug 09 22:13:15 CST 2018, time=2018-08-09, status=1, ipAttribution=)]
    2018-08-11 fusion

    #NICE#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1289029, encodeId=62c31289029f8, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Sat Aug 11 12:50:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337575, encodeId=6e4433e5756d, content=^_^^_^^_^, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Swp2ehfHpiciczeTntUyQOlIGMzQ705ic67sdMTVMbwTv7KbmlUvxrGvRSvQZjPkz7ib5tEDfIaORgczPtmHDpwojg/0, createdBy=c54b2163125, createdName=wqkm, createdTime=Thu Aug 09 22:28:05 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337574, encodeId=8da333e574f3, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Thu Aug 09 22:22:39 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337572, encodeId=4bff33e57276, content=不错的文章值得拥有哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Thu Aug 09 22:13:15 CST 2018, time=2018-08-09, status=1, ipAttribution=)]
    2018-08-09 wqkm

    ^_^^_^^_^

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1289029, encodeId=62c31289029f8, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Sat Aug 11 12:50:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337575, encodeId=6e4433e5756d, content=^_^^_^^_^, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Swp2ehfHpiciczeTntUyQOlIGMzQ705ic67sdMTVMbwTv7KbmlUvxrGvRSvQZjPkz7ib5tEDfIaORgczPtmHDpwojg/0, createdBy=c54b2163125, createdName=wqkm, createdTime=Thu Aug 09 22:28:05 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337574, encodeId=8da333e574f3, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Thu Aug 09 22:22:39 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337572, encodeId=4bff33e57276, content=不错的文章值得拥有哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Thu Aug 09 22:13:15 CST 2018, time=2018-08-09, status=1, ipAttribution=)]
    2018-08-09 天地飞扬

    了解一下，谢谢分享！

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1289029, encodeId=62c31289029f8, content=<a href='/topic/show?id=077112e9237' target=_blank style='color:#2F92EE;'>#NICE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12792, encryptionId=077112e9237, topicName=NICE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=743b215, createdName=fusion, createdTime=Sat Aug 11 12:50:00 CST 2018, time=2018-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337575, encodeId=6e4433e5756d, content=^_^^_^^_^, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/Swp2ehfHpiciczeTntUyQOlIGMzQ705ic67sdMTVMbwTv7KbmlUvxrGvRSvQZjPkz7ib5tEDfIaORgczPtmHDpwojg/0, createdBy=c54b2163125, createdName=wqkm, createdTime=Thu Aug 09 22:28:05 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337574, encodeId=8da333e574f3, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Thu Aug 09 22:22:39 CST 2018, time=2018-08-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=337572, encodeId=4bff33e57276, content=不错的文章值得拥有哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eff51996281, createdName=1e1b8538m79(暂无匿称), createdTime=Thu Aug 09 22:13:15 CST 2018, time=2018-08-09, status=1, ipAttribution=)]
    2018-08-09 1e1b8538m79(暂无匿称)

    不错的文章值得拥有哦

    0