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FDA认定rucaparib作为前列腺癌突破性疗法资格

2018-10-06 MedSci MedSci原创

rucaparib前列腺癌
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Clovis Oncology公司10月2日宣布，Rubraca (rucaparib)用于单药治疗既往接受过抗雄激素受体疗法以及紫杉烷类化疗的BRCA1/2+成人转移性去势抵抗前列腺癌（mCRPC）已被FDA授予突破性疗法资格。rucaparib之前也被FDA授予过单药治疗特定晚期卵巢癌患者的突破性疗法资格，并且在2016年12月19日被FDA批准用于单药治疗既往接受过两种以上化疗的BRCA突变

Clovis Oncology公司10月2日宣布，Rubraca (rucaparib)用于单药治疗既往接受过抗雄激素受体疗法以及紫杉烷类化疗的BRCA1/2+成人转移性去势抵抗前列腺癌（mCRPC）已被FDA授予突破性疗法资格。

rucaparib之前也被FDA授予过单药治疗特定晚期卵巢癌患者的突破性疗法资格，并且在2016年12月19日被FDA批准用于单药治疗既往接受过两种以上化疗的BRCA突变晚期卵巢癌患者，成为全球第2个上市的PARP抑制剂。2018年4月6日又被FDA批准用于复发的成人卵巢上皮癌、输卵管癌和原发性腹膜癌患者接受铂类药物化疗实现完全缓解或部分缓解后的维持治疗。2017年全球销售额是5700万美元。

前列腺癌是一种雄激素依赖的肿瘤，雄激素可以刺激前列腺癌细胞的生长和疾病进展。传统的内分泌治疗包括去势治疗以阻断睾丸来源的雄激素（手术切除双侧睾丸切除、注射戈舍瑞林等）、抗雄治疗（口服抗雄药物）以阻断肾上腺来源的雄激素。但随着疾病的进展，虽然睾丸和肾上腺来源的雄激素被阻断，但是肿瘤细胞自身生物合成雄激素的能力提高，发生突变的雄激素受体（AR）对于低水平的雄激素更加敏感，仍然可以驱动疾病进展，此时的疾病状态就是去势抵抗阶段的前列腺癌。

内分泌治疗的有效时间一般为18-24个月，几乎所有的晚期前列腺癌患者在接受内分泌治疗后都会最终进展为去势抵抗性前列腺癌（CPRC）。去势抵抗与前列腺癌的转移密切相关，而且转移性去势抵抗前列腺癌是一种无法治愈的疾病，预后很差。根据美国癌症学会统计，mCRPC的5年生存率大约为29%。

另据美国癌症学会统计，2018年美国预计有16.4万例新确诊前列腺癌患者。据JCO杂志2017年发布的一篇文章数据，mCRPC患者中大约有12%携带BRCA1或BRCA2突变。

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    2018-12-05 smlt2008

    #CAP#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1898018, encodeId=a85a1898018e2, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Wed Dec 05 00:48:00 CST 2018, time=2018-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338189, encodeId=8d00133818951, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, 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=Mon Oct 08 11:48:00 CST 2018, time=2018-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1536176, encodeId=240715361e616, 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=87, 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=Mon Oct 08 11:48:00 CST 2018, time=2018-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=348236, encodeId=5c83348236d1, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Sat Oct 06 21:06:00 CST 2018, time=2018-10-06, status=1, ipAttribution=)]
    2018-10-08 12498b3em08(暂无昵称)

    #APA#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1898018, encodeId=a85a1898018e2, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Wed Dec 05 00:48:00 CST 2018, time=2018-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338189, encodeId=8d00133818951, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, 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=Mon Oct 08 11:48:00 CST 2018, time=2018-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1536176, encodeId=240715361e616, 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=87, 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=Mon Oct 08 11:48:00 CST 2018, time=2018-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=348236, encodeId=5c83348236d1, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Sat Oct 06 21:06:00 CST 2018, time=2018-10-06, status=1, ipAttribution=)]
    2018-10-08 zhwj

    #突破性疗法#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1898018, encodeId=a85a1898018e2, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Wed Dec 05 00:48:00 CST 2018, time=2018-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1338189, encodeId=8d00133818951, content=<a href='/topic/show?id=cd2a262068' target=_blank style='color:#2F92EE;'>#APA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, 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=Mon Oct 08 11:48:00 CST 2018, time=2018-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1536176, encodeId=240715361e616, 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=87, 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=Mon Oct 08 11:48:00 CST 2018, time=2018-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=348236, encodeId=5c83348236d1, content=了解一下，谢谢分享！, beContent=null, objectType=article, channel=null, level=null, likeNumber=114, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cdnapi.center.medsci.cn/medsci/head/2019/12/23/2f51002e1349ccda5be11c1eea1e1e60.jpg, createdBy=a22097948, createdName=天地飞扬, createdTime=Sat Oct 06 21:06:00 CST 2018, time=2018-10-06, status=1, ipAttribution=)]
    2018-10-06 天地飞扬

    了解一下，谢谢分享！

    0

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FDA批准Clovis PARP抑制剂rucaparib

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Lancet：Rucaparib可用于经铂类化疗后缓解的复发性卵巢癌患者的维持治疗。

Rucaparib，PARP抑制剂，对携带BRCA突变或者大片段基因杂合缺失的复发性卵巢癌具有抗癌作用。在本试验中，研究人员评估Rucaparib用于经二线治疗或后以顺铂为基础的化疗获得完全或部分缓解的高级别、复发性、铂类药物敏感性卵巢癌患者维持治疗的效果。

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