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Keytruda/Alimta联合治疗NSCLC获美国FDA批准

2018-08-23 MedSci MedSci原创

Keytruda/Alimta联合治疗
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MSD的Keytruda与礼来公司的Alimta和铂化疗联合作为转移性非鳞状非小细胞肺癌的一线治疗药物在美国获得了完全的批准。扩大的批准允许医生治疗不携带任何EGFR或ALK突变的患者。这一决定基于III期KEYNOTE-189试验的数据，该试验表明，无论PD-L1肿瘤表达状况如何，联合治疗在总体生存率(OS)方面均显示出统计学意义重大且临床意义重大的改善，与单纯化疗相比，死亡风险降低了一半。Ke



MSD的Keytruda与礼来公司的Alimta和铂化疗联合作为转移性非鳞状非小细胞肺癌的一线治疗药物在美国获得了完全的批准。

扩大的批准允许医生治疗不携带任何EGFR或ALK突变的患者。

这一决定基于III期KEYNOTE-189试验的数据，该试验表明，无论PD-L1肿瘤表达状况如何，联合治疗在总体生存率(OS)方面均显示出统计学意义重大且临床意义重大的改善，与单纯化疗相比，死亡风险降低了一半。

Keytruda (pembrolizumab)联合Alimta (pemetrexed)和carboplatin于2017年根据II期KEYNOTE-021研究的肿瘤应答率和无进展生存数据，在FDA对转移性非鳞状非小细胞肺癌患者的一线治疗加速审批流程中首次获得批准。

该公司指出，现已在KEYNOTE-189中证实，持续批准取决于该药物在该环境中的临床益处的验证和描述。


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    2018-12-26 智者为医08

    #FDA批准#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1839618, encodeId=c2d4183961887, 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=53, 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=Wed Dec 26 17:48:00 CST 2018, time=2018-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1313712, encodeId=cd111313e1218, content=<a href='/topic/show?id=d4cc80e128f' target=_blank style='color:#2F92EE;'>#联合治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80712, encryptionId=d4cc80e128f, topicName=联合治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1368043, encodeId=0a3f1368043cb, content=<a href='/topic/show?id=de4912308e7' target=_blank style='color:#2F92EE;'>#MTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12308, encryptionId=de4912308e7, topicName=MTA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cb3a261, createdName=liuxiaona, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551414, encodeId=e535155141480, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=340353, encodeId=9ecd340353c8, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Thu Aug 23 09:52:16 CST 2018, time=2018-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=340349, encodeId=0d76340349a2, content=认真学习，不断进步，把经验分享给同好。点赞了！, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eb131638261, createdName=lietome24, createdTime=Thu Aug 23 09:40:43 CST 2018, time=2018-08-23, status=1, ipAttribution=)]
    2018-08-24 zhaozuguo

    #联合治疗#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1839618, encodeId=c2d4183961887, 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=53, 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=Wed Dec 26 17:48:00 CST 2018, time=2018-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1313712, encodeId=cd111313e1218, content=<a href='/topic/show?id=d4cc80e128f' target=_blank style='color:#2F92EE;'>#联合治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80712, encryptionId=d4cc80e128f, topicName=联合治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1368043, encodeId=0a3f1368043cb, content=<a href='/topic/show?id=de4912308e7' target=_blank style='color:#2F92EE;'>#MTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12308, encryptionId=de4912308e7, topicName=MTA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cb3a261, createdName=liuxiaona, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551414, encodeId=e535155141480, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=340353, encodeId=9ecd340353c8, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Thu Aug 23 09:52:16 CST 2018, time=2018-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=340349, encodeId=0d76340349a2, content=认真学习，不断进步，把经验分享给同好。点赞了！, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eb131638261, createdName=lietome24, createdTime=Thu Aug 23 09:40:43 CST 2018, time=2018-08-23, status=1, ipAttribution=)]
    2018-08-24 liuxiaona

    #MTA#

    0

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    2018-08-24 10518098zz

    #美国FDA#

    0

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    2018-08-23 易水河

    了解一下

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1839618, encodeId=c2d4183961887, 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=53, 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=Wed Dec 26 17:48:00 CST 2018, time=2018-12-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1313712, encodeId=cd111313e1218, content=<a href='/topic/show?id=d4cc80e128f' target=_blank style='color:#2F92EE;'>#联合治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=63, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80712, encryptionId=d4cc80e128f, topicName=联合治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1368043, encodeId=0a3f1368043cb, content=<a href='/topic/show?id=de4912308e7' target=_blank style='color:#2F92EE;'>#MTA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12308, encryptionId=de4912308e7, topicName=MTA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=cb3a261, createdName=liuxiaona, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551414, encodeId=e535155141480, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Fri Aug 24 23:48:00 CST 2018, time=2018-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=340353, encodeId=9ecd340353c8, content=了解一下, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKibA62IFMeUJEmSyIe8DvYFeERuOsfrRd8iano7nENqQU1dRR3tqeQOUL3eqgYgEZRT2t2iaEsib0JEw/132, createdBy=66771693911, createdName=易水河, createdTime=Thu Aug 23 09:52:16 CST 2018, time=2018-08-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=340349, encodeId=0d76340349a2, content=认真学习，不断进步，把经验分享给同好。点赞了！, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=eb131638261, createdName=lietome24, createdTime=Thu Aug 23 09:40:43 CST 2018, time=2018-08-23, status=1, ipAttribution=)]
    2018-08-23 lietome24

    认真学习，不断进步，把经验分享给同好。点赞了！

    0

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