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Keytruda联用化疗药物获得欧盟人用药品委员会批准用于转移性NSCLC的一线治疗

2018-08-01 MedSci MedSci原创

CHMP推荐将Keytruda与Alimta(培美曲塞)和铂类化疗药物(顺铂或卡铂)联合使用,用于无EGFR或ALK基因组突变的转移性非鳞状非小细胞肺癌(NSCLC)肺癌成人患者的一线治疗,不考虑PD-L1的表达水平。

根据欧洲药品管理局(EMA)人用药品委员会(CHMP)的积极推荐,默沙东(MSD)的Keytruda可能成为欧洲首个与化疗药物联用的抗PD-1药物。

CHMP推荐将Keytruda与Alimta(培美曲塞)和铂类化疗药物(顺铂或卡铂)联合使用,用于无EGFR或ALK基因组突变的转移性非鳞状非小细胞肺癌NSCLC肺癌成人患者的一线治疗,不考虑PD-L1的表达水平。该批准基于3期临床试验KEYNOTE-189的总生存期(OS)和无进展生存期(PFS)数据。

MSD研究实验室主席Roger Perlmutter博士表示:"肺癌是欧洲癌症死亡的主要原因,因此亟需开发出能够改善转移性NSCLC患者总生存期的创新疗法。"

CHMP也采取积极意见,建议批准Keytruda作为单药疗法用于治疗PD-L1阳性、肿瘤比例评分(TPS)≥50%且铂类化疗后无效的复发或转移性头颈部鳞状细胞癌(HNSCC)的成人患者。

这两项建议现在将由欧盟委员会审查以获得欧盟的上市许可,预计2018年第三季度将就这两项建议作出最终决定。

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    2018-08-06 jihuaijun1112

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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335760, encodeId=13d6335e6078, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/fhZdOu27e88Voqh19n8eF8cLplo8L4nicKtH0WnE3KFELXns5XDu8rsiceK2HHDZc2SEStia5VV3Pia2QLMVqlWbHw/0, createdBy=6e012139475, createdName=神功盖世, createdTime=Thu Aug 02 12:33:32 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-03 jihuaijun1112

    学习学习学习

    0

  8. 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    2018-08-03 jihuaijun1112

    学习学习学习

    0

  9. 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ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=335760, encodeId=13d6335e6078, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=58, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/fhZdOu27e88Voqh19n8eF8cLplo8L4nicKtH0WnE3KFELXns5XDu8rsiceK2HHDZc2SEStia5VV3Pia2QLMVqlWbHw/0, createdBy=6e012139475, createdName=神功盖世, createdTime=Thu Aug 02 12:33:32 CST 2018, time=2018-08-02, status=1, ipAttribution=)]
    2018-08-02 sunfeifeiyang

    学习

    0

  10. 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