AZ的肺癌药物Tagrisso在欧洲获准作为一线用药

2018-05-01 MedSci MedSci原创

欧洲的监管顾问支持阿斯利康公司的肺癌药物Tagrisso作为一线用药的批准。欧洲药品管理局人用药品委员会（CHMP）建议扩大该药品的标签，以包括表皮生长因子受体（EGFR）突变的成人局部晚期或转移性非小细胞肺癌（NSCLC）的成人一线治疗。该研究的首席医疗官Sean Bohen指出："该积极的建议承认Tagrisso的osimertinib具有欧洲EGFR突变NSCLC患者的一线治疗新标准的潜力。

欧洲的监管顾问支持阿斯利康公司的肺癌药物Tagrisso作为一线用药的批准。

欧洲药品管理局人用药品委员会（CHMP）建议扩大该药品的标签，以包括表皮生长因子受体（EGFR）突变的成人局部晚期或转移性非小细胞肺癌（NSCLC）的成人一线治疗。

该研究的首席医疗官Sean Bohen指出："该积极的建议承认Tagrisso的osimertinib具有欧洲EGFR突变NSCLC患者的一线治疗新标准的潜力。"

"它反映了FLAURA数据的优势，显示Tagrisso在所有预先设定的患者亚组中，包括那些有或没有中枢神经系统的患者，其EGFR-TKI比较组在改善无进展生存期方面具有显着的统计学差异和临床意义。"

根据这数据，在美国获得了批准。数据显示服用Tagrisso的患者的无进展生存期为18.9个月，而接受标准护理的患者的无进展生存期为10.2个月，而客观缓解率分别为80％与76％。

在日内瓦举行的欧洲肺癌会议（ELCC）上对FLAURA结果进行的一项新分析也显示，药物对EGFR酪氨酸激酶抑制剂（TKIs）的PFS益处在整个后续进展中持续存在。

Tagrisso最初被全球几个国家批准为EGFR T790M突变阳性晚期NSCLC患者的二线治疗药物。

此外，CHMP还建议扩大UCB Pharma SA的Cimzia（certolizumab pegol）治疗适用于全身治疗的成年人的斑块型银屑病的适应证； Amgen的Prolia (sumab)与长期系统性糖皮质激素治疗引起的骨质流失增加了骨折的风险相关； Bristol-Myers Squibb的Sprycel（达沙替尼）用于治疗新诊断Ph + CML慢性期或Ph + CML-CP耐药或不耐受包括伊马替尼在内的儿科患者；和辉瑞公司的Xeljanz（托法替尼）联合甲氨蝶呤治疗某些患者的活动性银屑病关节炎。

原文出处：http：//www.pharmatimes.com/news/az_lung_cancer_drug_tagrisso_backed_for_first-line_use_1233742

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2018-10-09 仁者大医

#AZ#

86 0
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2018-05-10 guicaiwei

好的

93 0
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2018-05-08 guicaiwei

好

88 0
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2018-05-06 guicaiwei

好

92 0
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2018-05-03 ms9474365431325850

#欧洲#

69 0
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2018-05-03 tsing_hit

#Tagrisso#

57 0
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2018-05-02 guicaiwei

很好

105 0
[GetPortalCommentsPageByObjectIdResponse(id=1714781, encodeId=9a4c1e14781c0, content=<a href='/topic/show?id=021230e312' target=_blank style='color:#2F92EE;'>#AZ#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=86, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3073, encryptionId=021230e312, topicName=AZ)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Tue Oct 09 08:21:00 CST 2018, time=2018-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=313886, encodeId=ebdf313886d6, content=好的, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/BHHqJOYCGO2Qnoy0HvW6a8484LMTViaaTLQricqaDrrg5shY907vventGeHZZgj5mlobGntCxX1JqYBgoEhLePCw/132, createdBy=a4312343135, createdName=guicaiwei, createdTime=Thu May 10 20:37:02 CST 2018, time=2018-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=313219, encodeId=eb0631321996, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/BHHqJOYCGO2Qnoy0HvW6a8484LMTViaaTLQricqaDrrg5shY907vventGeHZZgj5mlobGntCxX1JqYBgoEhLePCw/132, createdBy=a4312343135, createdName=guicaiwei, createdTime=Tue May 08 20:33:41 CST 2018, time=2018-05-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=312604, encodeId=e1a43126048f, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=92, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/BHHqJOYCGO2Qnoy0HvW6a8484LMTViaaTLQricqaDrrg5shY907vventGeHZZgj5mlobGntCxX1JqYBgoEhLePCw/132, createdBy=a4312343135, createdName=guicaiwei, createdTime=Sun May 06 18:29:57 CST 2018, time=2018-05-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1339081, encodeId=b4be133908116, content=<a href='/topic/show?id=447663054f5' target=_blank style='color:#2F92EE;'>#欧洲#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63054, encryptionId=447663054f5, topicName=欧洲)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEKxsKDoOOFxGpMibw6lsQFUIicWt7kWGevkdgFhjiban1icD2JdIBmjVo7qX7aSlCSpiaia382nuLKiaI3Cg/132, createdBy=5c442500150, createdName=ms9474365431325850, createdTime=Thu May 03 01:21:00 CST 2018, time=2018-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1385799, encodeId=2ffe1385e99d2, content=<a href='/topic/show?id=77371e08996' target=_blank style='color:#2F92EE;'>#Tagrisso#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17089, encryptionId=77371e08996, topicName=Tagrisso)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=dcaa509, createdName=tsing_hit, createdTime=Thu May 03 01:21:00 CST 2018, time=2018-05-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=311220, encodeId=0e92311220da, content=很好, beContent=null, objectType=article, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/BHHqJOYCGO2Qnoy0HvW6a8484LMTViaaTLQricqaDrrg5shY907vventGeHZZgj5mlobGntCxX1JqYBgoEhLePCw/132, createdBy=a4312343135, createdName=guicaiwei, createdTime=Wed May 02 07:43:06 CST 2018, time=2018-05-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=310976, encodeId=7c133109e6c2, content=学习了.长知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=96, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Tue May 01 11:37:16 CST 2018, time=2018-05-01, status=1, ipAttribution=)]
2018-05-01 1ddf0692m34(暂无匿称)

学习了.长知识

96 0

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AZ的肺癌药物Tagrisso在欧洲获准作为一线用药

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