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重磅！全球第二个CAR-T疗法获批上市！

2017-10-19 Chen 生物探索

全球第二个CAR-T疗法上市
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今天，CAR-T疗法再次刷屏朋友圈。继8月底FDA批准全球首款CAR-T疗法用于治疗急性淋巴细胞白血病后，10月18日，这一癌症免疫疗法领域再次收获好消息！FDA正式批准了全球第二个CAR-T疗法——Yescarta上市！

今天，CAR-T疗法再次刷屏朋友圈。继8月底FDA批准全球首款CAR-T疗法用于治疗急性淋巴细胞白血病后，10月18日，这一癌症免疫疗法领域再次收获好消息！FDA正式批准了全球第二个CAR-T疗法——Yescarta上市！

Yescarta（KTE-C19，axicabtagene ciloleucel）是一种靶向CD19的CAR-T疗法。FDA正式批准其用于治疗在接受至少2种其它治疗方案后无响应或复发的特定类型的大B细胞淋巴瘤成人患者。值得一提的是，Yescarta是首款获批用于治疗特定类型非霍奇金淋巴瘤（non-Hodgkin lymphoma，NHL）的基因疗法。

弥漫性大B细胞淋巴瘤（Diffuse large B-cell lymphoma，DLBCL）是成人中最常见的NHL。美国每年约有72000例NHL新病例被确诊，其中，DLBCL占了约三分之一。此次，Yescarta被批准的适应症包括DLBCL、原发性纵隔大B细胞淋巴瘤、高级B细胞淋巴瘤（high grade B-cell lymphoma）以及由滤泡性淋巴瘤引起的DLBCL。

Yescarta的安全性和有效性在一个包含100多名复发或难治性大B细胞淋巴瘤成人患者的多中心临床试验中得到了验证。Yescarta治疗后的完全缓解率为51%。此前，FDA曾授予Yescarta优先审评资格、突破性疗法认定以及孤儿药认定。

在毒性方面，Yescarta治疗可能会导致严重的副作用，其中包括了针对细胞因子释放综合症和神经系统毒性的“黑框警告”。这两种副作用都可能是致命的。其它的副作用包括严重感染、低血细胞计数和免疫系统变弱。

为了进一步评估长期的安全性，FDA要求制造商进行了一项有关患者接受Yescarta治疗的上市后观察性研究。

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1632543, encodeId=4660163254358, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Tue Jun 26 02:55:00 CST 2018, time=2018-06-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781191, encodeId=71dd1e81191d0, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sun Dec 10 03:55:00 CST 2017, time=2017-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549207, encodeId=f1b0154920ed5, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Oct 21 02:55:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254302, encodeId=59972543020d, content=很好的文章.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 19 12:36:31 CST 2017, time=2017-10-19, status=1, ipAttribution=)]
    2018-06-26 weiz

    #获批上市#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1632543, encodeId=4660163254358, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Tue Jun 26 02:55:00 CST 2018, time=2018-06-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781191, encodeId=71dd1e81191d0, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sun Dec 10 03:55:00 CST 2017, time=2017-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549207, encodeId=f1b0154920ed5, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Oct 21 02:55:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254302, encodeId=59972543020d, content=很好的文章.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 19 12:36:31 CST 2017, time=2017-10-19, status=1, ipAttribution=)]
    2017-12-10 仁者大医

    #CAR-#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1632543, encodeId=4660163254358, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Tue Jun 26 02:55:00 CST 2018, time=2018-06-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781191, encodeId=71dd1e81191d0, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sun Dec 10 03:55:00 CST 2017, time=2017-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549207, encodeId=f1b0154920ed5, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Oct 21 02:55:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254302, encodeId=59972543020d, content=很好的文章.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 19 12:36:31 CST 2017, time=2017-10-19, status=1, ipAttribution=)]
    2017-10-21 xxxx1054

    #重磅#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1632543, encodeId=4660163254358, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Tue Jun 26 02:55:00 CST 2018, time=2018-06-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1781191, encodeId=71dd1e81191d0, content=<a href='/topic/show?id=8ce8405907' target=_blank style='color:#2F92EE;'>#CAR-#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4059, encryptionId=8ce8405907, topicName=CAR-)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Sun Dec 10 03:55:00 CST 2017, time=2017-12-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1549207, encodeId=f1b0154920ed5, content=<a href='/topic/show?id=f7879600061' target=_blank style='color:#2F92EE;'>#重磅#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96000, encryptionId=f7879600061, topicName=重磅)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3acc14121561, createdName=xxxx1054, createdTime=Sat Oct 21 02:55:00 CST 2017, time=2017-10-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=254302, encodeId=59972543020d, content=很好的文章.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4o2XVpJ6449yqDsjibydI5HnJ8MibGxNn4HZiaZib0bdfibbwoz3KQrIyN9AGxq36ZlZRNicYlPfOOWMtwgsajY6mGNFiaPclFdowjD0/0, createdBy=97bd1338592, createdName=清风拂面, createdTime=Thu Oct 19 12:36:31 CST 2017, time=2017-10-19, status=1, ipAttribution=)]
    2017-10-19 清风拂面

    很好的文章.谢谢分享

    0

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