政策与人文

订阅

MedSci主页 / 所有栏目 / 政策与人文

经加速审查 FDA批准两款癌症治疗方案

2018-11-29 陈雯彦（编译） 环球网

加速审查癌症治疗方案
关注

美国有线电视新闻网11月28日报道，本周，美国食品和药物管理局(FDA)在加快审查后，批准了两种癌症治疗方法：Vitrakvi和Xospata。

美国有线电视新闻网11月28日报道，本周，美国食品和药物管理局(FDA)在加快审查后，批准了两种癌症治疗方法：Vitrakvi和Xospata。

Vitrakvi于11月26日获得批准，是一种针对具有特定遗传特征(生物标志物)的成人和儿童癌症患者的治疗方法。FDA在声明中说，这是第二种被批准的基于肿瘤生物标志物的癌症而不是基于肿瘤起源的身体部位的治疗方法。

Vtrakvi将用于治疗具有NTRK(神经营养受体酪氨酸激酶)基因融合的实体肿瘤。这种基因融合不具有已知的抗性突变，不进行转移或手术切除可能会导致严重的发病率，而且没有替代治疗。FDA表示，NTRK基因很少见，但存在于许多类型的癌症中，比如乳腺类似物分泌癌和婴儿纤维肉瘤。

根据美国食品和药物管理局的数据，28日批准的Xospata用于治疗患有FLT3突变的复发或难治性急性髓细胞白血病(AML)的成年患者。除了这款药片，美国食品和药物管理局还批准了一种诊断方法来检测这种突变。

美国食品和药物管理局肿瘤卓越中心主任理查德？帕兹杜尔(Richard Pazdur)博士在声明中表示，“大约有25%至30%的AML患者在FLT3基因中发生突变，这些突变可能会导致特别具有侵袭性的疾病形式以及更高的复发风险。”

FDA表示，AML是一种扩散迅速的癌症，它会影响正常血细胞的数量并要求连续输血。

两种治疗均被授予优先审查指定。

优先审查成立于1992年，即FDA会在六个月内完成药物或治疗的审查，而标准审查则需10个月。FDA表示：“优先审查将引导全面关注和资源评估药物申请，如果获得批准，与标准申请相比，将显着改善治疗、诊断或预防严重疾病的安全性或有效性。”

这两种治疗方法都获得了“孤儿药”称号，即针对罕见疾病或病症的药物。

原标题：经加速审查后 FDA批准两款癌症治疗方案

版权声明：
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料，版权均属于梅斯医学所有。非经授权，任何媒体、网站或个人不得转载，授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章，或“梅斯号”自媒体发布的文章，仅系出于传递更多信息之目的，本站仅负责审核内容合规，其内容不代表本站立场，本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系，我们将立即进行删除处理。
在此留言
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1844269, encodeId=0c601844269c1, 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=17, 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 Jun 09 23:50:00 CST 2019, time=2019-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839639, encodeId=cae11839639ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sat Dec 15 22:50:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905082, encodeId=80be190508287, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jan 13 00:50:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353984, encodeId=a5a5353984b0, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, 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 Nov 29 18:06:40 CST 2018, time=2018-11-29, status=1, ipAttribution=)]
    2019-06-09 陈吴1234

    #癌症治疗#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1844269, encodeId=0c601844269c1, 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=17, 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 Jun 09 23:50:00 CST 2019, time=2019-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839639, encodeId=cae11839639ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sat Dec 15 22:50:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905082, encodeId=80be190508287, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jan 13 00:50:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353984, encodeId=a5a5353984b0, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, 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 Nov 29 18:06:40 CST 2018, time=2018-11-29, status=1, ipAttribution=)]
    2018-12-15 智者为医08

    #FDA批准#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1844269, encodeId=0c601844269c1, 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=17, 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 Jun 09 23:50:00 CST 2019, time=2019-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839639, encodeId=cae11839639ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sat Dec 15 22:50:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905082, encodeId=80be190508287, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jan 13 00:50:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353984, encodeId=a5a5353984b0, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, 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 Nov 29 18:06:40 CST 2018, time=2018-11-29, status=1, ipAttribution=)]
    2019-01-13 zhangjiqing

    #治疗方案#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1844269, encodeId=0c601844269c1, 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=17, 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 Jun 09 23:50:00 CST 2019, time=2019-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839639, encodeId=cae11839639ff, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Sat Dec 15 22:50:00 CST 2018, time=2018-12-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1905082, encodeId=80be190508287, content=<a href='/topic/show?id=21f66464823' target=_blank style='color:#2F92EE;'>#治疗方案#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64648, encryptionId=21f66464823, topicName=治疗方案)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=5ee4187, createdName=zhangjiqing, createdTime=Sun Jan 13 00:50:00 CST 2019, time=2019-01-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=353984, encodeId=a5a5353984b0, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, 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 Nov 29 18:06:40 CST 2018, time=2018-11-29, status=1, ipAttribution=)]
    2018-11-29 天地飞扬

    了解一下，谢谢分享！

    0