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BI向EMA提交肺癌药物Nintedanib的上市许可申请

2013-10-16 fyc5078 dxy

肺癌药物
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勃林格殷格翰已向欧洲药品管理局(EMA)提交了公司旗下口服三联血管激酶抑制剂Nintedanib的上市许可申请。Nintedanib将与多西他赛联合用于治疗组织学诊断为腺癌的局部晚期、转移性或复发性非小细胞肺癌(NSCLC)。根据公司的信息，Nintedanib是首款初始治疗失败之后，在宽泛的腺癌患者人群中能延长患者生存期超一年以上的肺癌治疗药物。 勃林格殷格翰医学高级副总裁Klaus Dugi

勃林格殷格翰已向欧洲药品管理局(EMA)提交了公司旗下口服三联血管激酶抑制剂Nintedanib的上市许可申请。Nintedanib将与多西他赛联合用于治疗组织学诊断为腺癌的局部晚期、转移性或复发性非小细胞肺癌(NSCLC)。根据公司的信息，Nintedanib是首款初始治疗失败之后，在宽泛的腺癌患者人群中能延长患者生存期超一年以上的肺癌治疗药物。

勃林格殷格翰医学高级副总裁Klaus Dugi表示，Nintedanib是公司新肿瘤药物研究计划之外的一个化合物，也是公司向EMA提交的产品组合中第二个化合物。“改善患者的生存仍是勃林格殷格翰在肿瘤治疗进展上所承诺的以证据为基础的重点。”Dugi补充说。

腺癌是最常见的肺癌类型，当根治性治疗不再可能时有超过三分之二的患者在晚期会被确诊为这种疾病，并且所有患者的病情将进展，需要二线治疗。

欧盟上市许可申请基于国际、双盲、III期LUME-Lung1临床试验结果，该试验将Nintedanib和多西他赛合并用药与多西他赛和安慰剂合并用药进行了对比。试验结果表明，患者一线化疗失败后，安慰剂组患者在中位总生存期10.3个月，而Nintedanib组中位总体生存时间为12.6个月。

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    2013-10-20 xinxin088

    #上市许可#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1694078, encodeId=c89d16940e813, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Sun Oct 20 03:32:00 CST 2013, time=2013-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1702913, encodeId=2d991e029132a, content=<a href='/topic/show?id=72351e25437' target=_blank style='color:#2F92EE;'>#TED#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17254, encryptionId=72351e25437, topicName=TED)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=76e230462388, createdName=aliceclz, createdTime=Thu Feb 27 12:32:00 CST 2014, time=2014-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317207, encodeId=e404131e20761, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Fri Oct 18 04:32:00 CST 2013, time=2013-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361776, encodeId=30fa1361e76fc, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Fri Oct 18 04:32:00 CST 2013, time=2013-10-18, status=1, ipAttribution=)]
    2014-02-27 aliceclz

    #TED#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1694078, encodeId=c89d16940e813, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Sun Oct 20 03:32:00 CST 2013, time=2013-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1702913, encodeId=2d991e029132a, content=<a href='/topic/show?id=72351e25437' target=_blank style='color:#2F92EE;'>#TED#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17254, encryptionId=72351e25437, topicName=TED)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=76e230462388, createdName=aliceclz, createdTime=Thu Feb 27 12:32:00 CST 2014, time=2014-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317207, encodeId=e404131e20761, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Fri Oct 18 04:32:00 CST 2013, time=2013-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361776, encodeId=30fa1361e76fc, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Fri Oct 18 04:32:00 CST 2013, time=2013-10-18, status=1, ipAttribution=)]
    2013-10-18 fengyi812

    #EMA#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1694078, encodeId=c89d16940e813, content=<a href='/topic/show?id=adb8198e07a' target=_blank style='color:#2F92EE;'>#上市许可#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19870, encryptionId=adb8198e07a, topicName=上市许可)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=xinxin088, createdTime=Sun Oct 20 03:32:00 CST 2013, time=2013-10-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1702913, encodeId=2d991e029132a, content=<a href='/topic/show?id=72351e25437' target=_blank style='color:#2F92EE;'>#TED#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17254, encryptionId=72351e25437, topicName=TED)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=76e230462388, createdName=aliceclz, createdTime=Thu Feb 27 12:32:00 CST 2014, time=2014-02-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317207, encodeId=e404131e20761, content=<a href='/topic/show?id=74916e0414' target=_blank style='color:#2F92EE;'>#EMA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6704, encryptionId=74916e0414, topicName=EMA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a35a460, createdName=fengyi812, createdTime=Fri Oct 18 04:32:00 CST 2013, time=2013-10-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1361776, encodeId=30fa1361e76fc, content=<a href='/topic/show?id=131d12808f9' target=_blank style='color:#2F92EE;'>#Nintedanib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12808, encryptionId=131d12808f9, topicName=Nintedanib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce68183, createdName=xiongke010, createdTime=Fri Oct 18 04:32:00 CST 2013, time=2013-10-18, status=1, ipAttribution=)]
    2013-10-18 xiongke010

    #Nintedanib#

    0