Clovis的Rubraca超越了多个PARP抑制剂竞争对手,在前列腺癌领域获得FDA的优先审查

2020-01-17 不详 MedSci原创

FDA刚刚开始对Rubraca(rucaparib)进行为期六个月的优先审查,判决将于5月15日之前完成,用作BRCA1 / 2突变的复发或转移的去势抵抗性前列腺癌(CRPC)成人的单一疗法。BRCA1 / 2基因突变是mCRPC患者最常见的缺陷。

FDA刚刚开始对Rubraca(rucaparib)进行为期六个月的优先审查,判决将于5月15日之前完成,用作BRCA1 / 2突变的复发或转移的去势抵抗性前列腺癌(CRPC)成人的单一疗法。BRCA1 / 2基因突变是mCRPC患者最常见的缺陷。

克洛维斯(Clovis)正在寻求将Rubraca批准用于,已接受过一轮基于紫杉烷类化疗以及至少一种较新的激素制剂(例如强生公司的Zytiga(阿比特龙)或辉瑞公司的Xtandi(恩杂鲁胺))的患者。

目前,它被用作卵巢癌、输卵管癌和原发性腹膜癌化疗后的维持治疗,并被用于这些癌症中BRCA突变的复发患者的三线及以后的治疗。

如果在前列腺癌中获得批准,Rubraca将是此类实体瘤中的第一个靶向治疗药物。

该文件意味着Rubraca在PARP抑制剂领域,击败了阿斯利康/默克公司的市场领先者Lynparza(olaparib),葛兰素史克/詹森的Zejula(尼拉帕利布)和辉瑞的新进入者Talzenna(他拉唑帕尼)等竞争对手,在前列腺癌中大放异彩。

就市场份额而言,Clovis Oncology的Rubraca在PARP抑制剂中表现很一般,但前列腺癌的一线治疗获批很可能会进一步推动该产品的发展。

Clovis的申请基于TRITON试验计划的结果,尤其是TRITON2研究,该研究显示Rubraca在BRCA突变的CRPC中有44%的应答率,以及52%的前列腺特异性抗原(PSA)应答。

Rubraca与百时美施贵宝的免疫检查点抑制剂Opdivo(nivolumab)的组合试验CheckMate 9KD也在进行中,并将于今年晚些时候取得初步结果。

原始出处:


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    2020-10-05 lishizhe
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    2020-12-01 jklm09
  5. [GetPortalCommentsPageByObjectIdResponse(id=2054905, encodeId=17c6205490553, content=<a href='/topic/show?id=6173486930' target=_blank style='color:#2F92EE;'>#Clovis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4869, encryptionId=6173486930, topicName=Clovis)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqTLTjicBiccpdUyHMGZV43nOBI6QIQqxVcy2EzXz67E390Q5j0R7QWjym391HxsyiaYt7NzbrcojRDw/132, createdBy=64462500151, createdName=ms705947299214030, createdTime=Sat Sep 05 13:09:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1651957, encodeId=aec7165195e25, content=<a href='/topic/show?id=3a3e1e9504' target=_blank style='color:#2F92EE;'>#ACA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1795, encryptionId=3a3e1e9504, topicName=ACA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=843c24278901, createdName=lishizhe, createdTime=Mon Oct 05 04:09:00 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1993301, encodeId=5a36199330179, content=<a href='/topic/show?id=c1d115e3632' target=_blank style='color:#2F92EE;'>#rubraca#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15736, encryptionId=c1d115e3632, topicName=rubraca)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Oct 03 01:09:00 CST 2020, time=2020-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852250, encodeId=79d1185225057, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Tue Dec 01 07:09:00 CST 2020, time=2020-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400149, encodeId=ae951400149a2, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Sun Jan 19 12:09:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621356, encodeId=20f616213561f, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Jan 19 12:09:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040648, encodeId=db80104064834, content=前列腺癌相关研究,学习了,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sat Jan 18 00:09:00 CST 2020, time=2020-01-18, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=2054905, encodeId=17c6205490553, content=<a href='/topic/show?id=6173486930' target=_blank style='color:#2F92EE;'>#Clovis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4869, encryptionId=6173486930, topicName=Clovis)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqTLTjicBiccpdUyHMGZV43nOBI6QIQqxVcy2EzXz67E390Q5j0R7QWjym391HxsyiaYt7NzbrcojRDw/132, createdBy=64462500151, createdName=ms705947299214030, createdTime=Sat Sep 05 13:09:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1651957, encodeId=aec7165195e25, content=<a href='/topic/show?id=3a3e1e9504' target=_blank style='color:#2F92EE;'>#ACA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1795, encryptionId=3a3e1e9504, topicName=ACA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=843c24278901, createdName=lishizhe, createdTime=Mon Oct 05 04:09:00 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1993301, encodeId=5a36199330179, content=<a href='/topic/show?id=c1d115e3632' target=_blank style='color:#2F92EE;'>#rubraca#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15736, encryptionId=c1d115e3632, topicName=rubraca)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Oct 03 01:09:00 CST 2020, time=2020-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852250, encodeId=79d1185225057, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Tue Dec 01 07:09:00 CST 2020, time=2020-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400149, encodeId=ae951400149a2, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Sun Jan 19 12:09:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621356, encodeId=20f616213561f, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Jan 19 12:09:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040648, encodeId=db80104064834, content=前列腺癌相关研究,学习了,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sat Jan 18 00:09:00 CST 2020, time=2020-01-18, status=1, ipAttribution=)]
    2020-01-19 zhaojie88
  7. [GetPortalCommentsPageByObjectIdResponse(id=2054905, encodeId=17c6205490553, content=<a href='/topic/show?id=6173486930' target=_blank style='color:#2F92EE;'>#Clovis#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4869, encryptionId=6173486930, topicName=Clovis)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83eqTLTjicBiccpdUyHMGZV43nOBI6QIQqxVcy2EzXz67E390Q5j0R7QWjym391HxsyiaYt7NzbrcojRDw/132, createdBy=64462500151, createdName=ms705947299214030, createdTime=Sat Sep 05 13:09:00 CST 2020, time=2020-09-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1651957, encodeId=aec7165195e25, content=<a href='/topic/show?id=3a3e1e9504' target=_blank style='color:#2F92EE;'>#ACA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1795, encryptionId=3a3e1e9504, topicName=ACA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=843c24278901, createdName=lishizhe, createdTime=Mon Oct 05 04:09:00 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1993301, encodeId=5a36199330179, content=<a href='/topic/show?id=c1d115e3632' target=_blank style='color:#2F92EE;'>#rubraca#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15736, encryptionId=c1d115e3632, topicName=rubraca)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Bnia2EtH2IvyBtniaWHPQOYAicsN3IAL1ZuPV7qyALcdCiawRJdEiafMxWTxzERQW7eeKg8HfCKCRK2CJicy073C4RJg/132, createdBy=464b2500186, createdName=ms1948154235210413, createdTime=Sat Oct 03 01:09:00 CST 2020, time=2020-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1852250, encodeId=79d1185225057, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Tue Dec 01 07:09:00 CST 2020, time=2020-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400149, encodeId=ae951400149a2, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Sun Jan 19 12:09:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1621356, encodeId=20f616213561f, content=<a href='/topic/show?id=49b313e56ad' target=_blank style='color:#2F92EE;'>#PARP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13756, encryptionId=49b313e56ad, topicName=PARP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sun Jan 19 12:09:00 CST 2020, time=2020-01-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040648, encodeId=db80104064834, content=前列腺癌相关研究,学习了,谢谢梅斯, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sat Jan 18 00:09:00 CST 2020, time=2020-01-18, status=1, ipAttribution=)]
    2020-01-18 misszhang

    前列腺癌相关研究,学习了,谢谢梅斯

    0

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