新癌症治疗技术导致病人死亡FDA紧急叫停

2017-09-06 佚名 网易科技

据美国媒体报道,就在美国食品药品管理局(FDA)批准制药公司诺华使用新的癌症治疗技术CAR-T一周后,该机构暂停了后面的试验,原因是用这种技术治疗的病人出现首例死亡病例。

据美国媒体报道,就在美国食品药品管理局(FDA)批准制药公司诺华使用新的癌症治疗技术CAR-T一周后,该机构暂停了后面的试验,原因是用这种技术治疗的病人出现首例死亡病例。

CAR-T是使用病人自己的免疫细胞治疗癌症,这些细胞被提取后将被修改以携带新基因,然后重新植入到病人身体中。当前的试验本是测试用捐献者免疫细胞而非病人细胞的CAR-T治疗技术的效果。《麻省理工科技评论》称,这种修改后的治疗技术被称为“现成”或“通用”CAR-T。

法国生物制药公司Cellectis在9月4日宣布了FDA的决定,并透露这位病人是78岁的罹患“母细胞性浆细胞样树突状细胞肿瘤”(BPDCN)的男性。该病人只注射了一剂药,就在治疗8天后因致命反应而死亡。FDA还进一步暂停了对白血病的CAR-T治疗实验,虽然年初的试验证明对2个婴儿有效。

持续影响

Cellectis不是首家在药品试验中导致病人死亡的公司:去年生物制药公司Juno Therapeutics在7位病人死亡后暂停了试验。后来FDA介入,但在改变了试验方法后允许其继续试验。随着更多的病人死亡,该公司被要求停止一切试验。

Cellectis还要面对投资者的质疑,因为在声明发布后公司股价下跌。如果安全措施不到位,FDA可能不会很快恢复试验。其他参与CAR-T试验的公司,或希望获得同意批准的公司如诺华也一样。Kite Pharma本希望年底获得批准,但Cellectis事件可能导致推迟。

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    2017-09-23 1e207054m17(暂无匿称)

    新技术.要有充分证据

    0

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    2017-09-15 三生有幸9135

    学习一下谢谢分享

    0

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  4. 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encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Fri Sep 08 13:23:00 CST 2017, time=2017-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241510, encodeId=207d2415104a, content=很好.学习了.很有帮助., beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Thu Sep 07 19:39:41 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241405, encodeId=a38c241405df, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, 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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 Sep 07 07:48:53 CST 2017, time=2017-09-07, status=1, ipAttribution=)]
    2017-09-13 189****7206

    学习了谢谢分享

    0

  5. 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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 Sep 07 07:48:53 CST 2017, time=2017-09-07, status=1, ipAttribution=)]
    2017-09-10 184****9840

    学习了谢谢分享

    0

  6. 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encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Fri Sep 08 13:23:00 CST 2017, time=2017-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241510, encodeId=207d2415104a, content=很好.学习了.很有帮助., beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Thu Sep 07 19:39:41 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241405, encodeId=a38c241405df, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, 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  7. 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GetPortalCommentsPageByObjectIdResponse(id=1844235, encodeId=915c18442352f, content=<a href='/topic/show?id=06a2e1405a8' target=_blank style='color:#2F92EE;'>#癌症治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71405, encryptionId=06a2e1405a8, topicName=癌症治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cbf451, createdName=陈吴1234, createdTime=Sun Sep 17 13:23:00 CST 2017, time=2017-09-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=243705, encodeId=44fb243e05a0, content=学习了谢谢分享, 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/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=08bb2061153, createdName=189****7206, createdTime=Wed Sep 13 23:45:52 CST 2017, time=2017-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=242404, encodeId=477224240465, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Sep 10 07:08:58 CST 2017, time=2017-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1523211, encodeId=21811523211c9, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Fri Sep 08 13:23:00 CST 2017, time=2017-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241510, encodeId=207d2415104a, content=很好.学习了.很有帮助., beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Thu Sep 07 19:39:41 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241405, encodeId=a38c241405df, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160914/IMG57D82E721DB581755.jpg, createdBy=4fc81933929, createdName=明天会更好!, createdTime=Thu Sep 07 09:18:51 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241369, encodeId=d5fd2413692c, content=不错哦.挺好, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Thu Sep 07 08:14:02 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241359, encodeId=74c724135900, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Sep 07 07:48:53 CST 2017, time=2017-09-07, status=1, ipAttribution=)]
    2017-09-07 李东泽

    很好.学习了.很有帮助.

    0

  8. 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createdName=189****7206, createdTime=Wed Sep 13 23:45:52 CST 2017, time=2017-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=242404, encodeId=477224240465, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Sep 10 07:08:58 CST 2017, time=2017-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1523211, encodeId=21811523211c9, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Fri Sep 08 13:23:00 CST 2017, time=2017-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241510, encodeId=207d2415104a, content=很好.学习了.很有帮助., beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Thu Sep 07 19:39:41 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241405, encodeId=a38c241405df, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160914/IMG57D82E721DB581755.jpg, createdBy=4fc81933929, createdName=明天会更好!, createdTime=Thu Sep 07 09:18:51 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241369, encodeId=d5fd2413692c, content=不错哦.挺好, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Thu Sep 07 08:14:02 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241359, encodeId=74c724135900, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Sep 07 07:48:53 CST 2017, time=2017-09-07, status=1, ipAttribution=)]
    2017-09-07 明天会更好!

    学习了很有用不错

    0

  9. 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topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160914/IMG57D82E721DB581755.jpg, createdBy=4fc81933929, createdName=明天会更好!, createdTime=Thu Sep 07 09:18:51 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241369, encodeId=d5fd2413692c, content=不错哦.挺好, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Thu Sep 07 08:14:02 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241359, encodeId=74c724135900, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Sep 07 07:48:53 CST 2017, time=2017-09-07, status=1, ipAttribution=)]
    2017-09-07 飛歌

    不错哦.挺好

    0

  10. 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createdName=189****7206, createdTime=Wed Sep 13 23:45:52 CST 2017, time=2017-09-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=242404, encodeId=477224240465, content=学习了谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib06iaV3D9Tg5Kzuf9u71gZhPYMiajRtENwicoAABeQtfXOlic8ibhYSy6DvJZWUDVtjRvTfqBffr1XJ6JLtFB5kHicthl/0, createdBy=d41c2055892, createdName=184****9840, createdTime=Sun Sep 10 07:08:58 CST 2017, time=2017-09-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1523211, encodeId=21811523211c9, content=<a href='/topic/show?id=1a1de7006b0' target=_blank style='color:#2F92EE;'>#紧急#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77006, encryptionId=1a1de7006b0, topicName=紧急)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b88211514540, createdName=guguangxiang, createdTime=Fri Sep 08 13:23:00 CST 2017, time=2017-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241510, encodeId=207d2415104a, content=很好.学习了.很有帮助., beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzUn81b5CF5ibVPib8jWI92iciaxmqGHlwruOnK4SVZykd4iahqo1hicklIibyZoxm55X7EM8BW9eX1h1hQ2/0, createdBy=8aa81937526, createdName=李东泽, createdTime=Thu Sep 07 19:39:41 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241405, encodeId=a38c241405df, content=学习了很有用不错, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20160914/IMG57D82E721DB581755.jpg, createdBy=4fc81933929, createdName=明天会更好!, createdTime=Thu Sep 07 09:18:51 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241369, encodeId=d5fd2413692c, content=不错哦.挺好, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/oLAjfB7s1ib3IzoRn621JdKCFUI4XvNELcibocrAVU6aUzEVDSaf3rYH08PUYUiagGqxAEhj8g9WqqNvD1CupIpCrmnR2OrqHZh/0, createdBy=7f181365728, createdName=飛歌, createdTime=Thu Sep 07 08:14:02 CST 2017, time=2017-09-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=241359, encodeId=74c724135900, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, 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 Sep 07 07:48:53 CST 2017, time=2017-09-07, status=1, ipAttribution=)]
    2017-09-07 明月清辉

    谢谢分享.学习了

    0

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