Janssen宣布FDA授予其PARP抑制剂Niraparib治疗转移性去势抵抗性前列腺癌的突破性疗法指定

2019-10-04 不详 MedSci原创m

强生宣布,美国食品药品监督管理局(FDA)授予其口服聚ADP-核糖聚合酶(PARP)抑制剂Niraparib的突破性治疗称号,用于先前接受过紫杉醇化疗和雄激素受体(AR)靶向治疗的BRCA1 / 2基因突变的转移性去势抵抗性前列腺癌(mCRPC)患者。

强生宣布,美国食品药品监督管理局(FDA)授予其口服聚ADP-核糖聚合酶(PARP)抑制剂Niraparib的突破性治疗称号,用于先前接受过紫杉醇化疗和雄激素受体(AR)靶向治疗的BRCA1 / 2基因突变的转移性去势抵抗性前列腺癌(mCRPC)患者。

授予突破性疗法称号是为了加快治疗严重或危及生命疾病的研究药物的开发和法规审查。突破性疗法指定需要初步的临床证据,证明该药物在至少一个临床上显着的终点上可能比现有疗法有实质性的改善。

BRCA1 / 2突变是mCRPC患者中最常见的DNA修复基因缺陷(DRD)。BRCA1 / 2的DRD患者患前列腺癌和更具侵略性疾病的风险较高。

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    2020-02-15 jklm09
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topicList=[TopicDto(id=55315, encryptionId=6f7d553159c, topicName=抗性)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4d5926034382, createdName=yige2012, createdTime=Fri Jun 19 10:09:00 CST 2020, time=2020-06-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338198, encodeId=cee91338198a5, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2620, encryptionId=cd2a262068, topicName=APA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce072500140, createdName=12498b3em08(暂无昵称), createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1342108, encodeId=12e81342108ec, content=<a href='/topic/show?id=da143e23485' target=_blank style='color:#2F92EE;'>#去势抵抗性前列腺癌#</a>, 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createdName=1249842em09(暂无昵称), createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1527093, encodeId=b04d152e093a3, content=<a href='/topic/show?id=ad4410248b5' target=_blank style='color:#2F92EE;'>#Janssen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10248, encryptionId=ad4410248b5, topicName=Janssen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1536189, encodeId=f990153618915, content=<a href='/topic/show?id=75fbe553800' target=_blank style='color:#2F92EE;'>#突破性疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75538, encryptionId=75fbe553800, topicName=突破性疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eca12667393, createdName=zhwj, createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581376, encodeId=14a915813e6de, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=)]
    2020-06-19 yige2012
  5. 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  6. 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  7. 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  8. 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createdName=1249842em09(暂无昵称), createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1527093, encodeId=b04d152e093a3, content=<a href='/topic/show?id=ad4410248b5' target=_blank style='color:#2F92EE;'>#Janssen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10248, encryptionId=ad4410248b5, topicName=Janssen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=hb2008ye, createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1536189, encodeId=f990153618915, content=<a href='/topic/show?id=75fbe553800' target=_blank style='color:#2F92EE;'>#突破性疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75538, encryptionId=75fbe553800, topicName=突破性疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eca12667393, createdName=zhwj, createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1581376, encodeId=14a915813e6de, content=<a href='/topic/show?id=8d991281805' target=_blank style='color:#2F92EE;'>#Niraparib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12818, encryptionId=8d991281805, topicName=Niraparib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=855416780985, createdName=12498bb3m95(暂无昵称), createdTime=Sun Oct 06 10:09:00 CST 2019, time=2019-10-06, status=1, ipAttribution=)]
    2019-10-06 hb2008ye
  9. 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