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FDA批准Gavreto(pralsetinib)治疗转移性RET融合阳性非小细胞肺癌

2020-09-07 Allan MedSci原创

罗氏集团成员Genentech今天宣布,美国食品药品监督管理局(FDA)已批准Gavreto™(pralsetinib)用于治疗转移性RET融合阳性非小细胞肺癌(NSCLC)患者。

RET融合和突变是许多癌症类型(包括NSCLC和甲状腺髓样癌)中的关键疾病因素。在NSCLC中,RET融合约占所有患者的1-2%。

罗氏集团成员Genentech今天宣布,美国食品药品监督管理局(FDA)已批准Gavreto™(pralsetinib)用于治疗转移性RET融合阳性非小细胞肺癌(NSCLC)患者。该项批准得到了I / II期ARROW研究数据的支持。

I / II期ARROW研究显示,Gavreto在患有RET融合阳性NSCLC的患者中,无论中枢神经系统受累如何,Gavreto都能产生持久的临床反应。Gavreto在先前接受铂类化学疗法治疗的87例NSCLC患者中显示出总缓解率(ORR)为57%、完全缓解(CR)率为5.7%。在27名未接受过治疗的非小细胞肺癌患者中,ORR为70%,CR率为11%。最常见的不良反应(≥25%)是疲劳、便秘、肌肉骨骼疼痛和高血压。

Genentech首席医学官兼全球产品开发主管Levi Garraway博士说:“我们仍然致力于根据特定的基因组或分子变化为癌症患者找到个体化的治疗选择,我们期待与Blueprint Medicines合作,进一步探索Gavreto在多种RET改变的肿瘤类型中的潜力”。

 

原始出处:

https://www.firstwordpharma.com/node/1755240?tsid=4

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    2020-10-11 bugit
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objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4gCIdSaEkahCNuUWZv4iaKmqvUKHyKnBiarBM9RStQKBeV5Lh6GYYFiamdV5KlSfbLvmAgZTLtq81XA/0, createdBy=13511650672, createdName=言西早, createdTime=Tue Sep 08 02:36:31 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=2045853, encodeId=563c20458533c, content=<a href='/topic/show?id=ecf49e5173d' target=_blank style='color:#2F92EE;'>#阳性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97517, encryptionId=ecf49e5173d, topicName=阳性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Wed Jun 30 01:11:16 CST 2021, time=2021-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839869, encodeId=d05a18398697c, 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=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Sun Oct 11 08:11:16 CST 2020, time=2020-10-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2086413, encodeId=821e2086413cf, content=<a href='/topic/show?id=134b304456' target=_blank style='color:#2F92EE;'>#AVR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3044, encryptionId=134b304456, topicName=AVR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7d74253, createdName=wangtianj2007@, createdTime=Wed Mar 17 19:11:16 CST 2021, time=2021-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059930, encodeId=2b44205993062, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Thu Dec 17 06:11:16 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1913941, encodeId=a2e719139418e, content=<a href='/topic/show?id=4684153e41f' target=_blank style='color:#2F92EE;'>#RET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15374, encryptionId=4684153e41f, topicName=RET)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=96d4340, createdName=ysjykql, createdTime=Fri Oct 09 12:11:16 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386662, encodeId=a66f1386662ff, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Wed Sep 09 03:11:16 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525553, encodeId=0eb51525553ad, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Wed Sep 09 03:11:16 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587731, encodeId=b18d158e731e8, content=<a href='/topic/show?id=06f51853363' target=_blank style='color:#2F92EE;'>#VRE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18533, encryptionId=06f51853363, topicName=VRE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95d617567021, createdName=lidong46, createdTime=Wed Sep 09 03:11:16 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883484, encodeId=19d888348470, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=142, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Tue Sep 08 07:23:59 CST 2020, time=2020-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883468, encodeId=1144883468db, content=科技改变生活改变命运。, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4gCIdSaEkahCNuUWZv4iaKmqvUKHyKnBiarBM9RStQKBeV5Lh6GYYFiamdV5KlSfbLvmAgZTLtq81XA/0, createdBy=13511650672, createdName=言西早, createdTime=Tue Sep 08 02:36:31 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
    2020-10-09 ysjykql
  6. 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  7. [GetPortalCommentsPageByObjectIdResponse(id=2045853, encodeId=563c20458533c, content=<a href='/topic/show?id=ecf49e5173d' target=_blank style='color:#2F92EE;'>#阳性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97517, encryptionId=ecf49e5173d, topicName=阳性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Wed Jun 30 01:11:16 CST 2021, time=2021-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839869, encodeId=d05a18398697c, 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=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, 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encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Thu Dec 17 06:11:16 CST 2020, time=2020-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1913941, encodeId=a2e719139418e, content=<a href='/topic/show?id=4684153e41f' target=_blank style='color:#2F92EE;'>#RET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15374, encryptionId=4684153e41f, topicName=RET)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=96d4340, createdName=ysjykql, createdTime=Fri Oct 09 12:11:16 CST 2020, time=2020-10-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386662, encodeId=a66f1386662ff, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Wed Sep 09 03:11:16 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1525553, encodeId=0eb51525553ad, content=<a href='/topic/show?id=08548885835' target=_blank style='color:#2F92EE;'>#融合#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=82, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88858, encryptionId=08548885835, topicName=融合)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=08a911636812, createdName=licz0427, createdTime=Wed Sep 09 03:11:16 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587731, encodeId=b18d158e731e8, content=<a href='/topic/show?id=06f51853363' target=_blank style='color:#2F92EE;'>#VRE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=91, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18533, encryptionId=06f51853363, topicName=VRE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=95d617567021, createdName=lidong46, createdTime=Wed Sep 09 03:11:16 CST 2020, time=2020-09-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883484, encodeId=19d888348470, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=142, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Tue Sep 08 07:23:59 CST 2020, time=2020-09-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=883468, encodeId=1144883468db, content=科技改变生活改变命运。, beContent=null, objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4gCIdSaEkahCNuUWZv4iaKmqvUKHyKnBiarBM9RStQKBeV5Lh6GYYFiamdV5KlSfbLvmAgZTLtq81XA/0, createdBy=13511650672, createdName=言西早, createdTime=Tue Sep 08 02:36:31 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
    2020-09-09 licz0427
  8. 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objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4gCIdSaEkahCNuUWZv4iaKmqvUKHyKnBiarBM9RStQKBeV5Lh6GYYFiamdV5KlSfbLvmAgZTLtq81XA/0, createdBy=13511650672, createdName=言西早, createdTime=Tue Sep 08 02:36:31 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
    2020-09-09 lidong46
  9. 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objectType=article, channel=null, level=null, likeNumber=139, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/Q3auHgzwzM4gCIdSaEkahCNuUWZv4iaKmqvUKHyKnBiarBM9RStQKBeV5Lh6GYYFiamdV5KlSfbLvmAgZTLtq81XA/0, createdBy=13511650672, createdName=言西早, createdTime=Tue Sep 08 02:36:31 CST 2020, time=2020-09-08, status=1, ipAttribution=)]
    2020-09-08 14818eb4m67暂无昵称

    学习

    0

  10. 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    2020-09-08 言西早

    科技改变生活改变命运。

    0

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