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FDA批准口服GnRH受体拮抗剂Orgovyx治疗晚期前列腺癌

2020-12-20 Allan MedSci原创

美国食品药品监督管理局(FDA)近日表示,已批准Myovant Sciences的GnRH受体拮抗剂Orgovyx(relugolix)治疗晚期前列腺癌患者。

前列腺癌(Prostate cancer)是出自前列腺的恶性肿瘤。大多数前列腺癌生长速度较为缓慢,但仍有些生长相对快速。癌细胞可转移到骨头和淋巴结等部位。前列腺癌早期可能没有症状,晚期可导致排尿困难、尿血、背痛、骨盆疼痛等症状。

美国食品药品监督管理局(FDA)近日表示,已批准Myovant Sciences的GnRH受体拮抗剂Orgovyx(relugolix)治疗晚期前列腺癌患者。

该项批准得到了HERO试验的支持,该试验对900多例雄激素敏感的晚期前列腺癌患者进行了至少一年的持续雄激素剥夺治疗。患者随机接受每天一次Orgovyx或激素靶向药物亮丙瑞林的治疗。

结果显示,Orgovyx达到了主要疗效终点,在48周内,在接受治疗的患者中,96.7%的患者实现了持续的睾丸激素抑制,去势水平低于50 ng / dL,而亮丙瑞林为88.8%。然而,结果显示该药物与亮丙瑞林相比,不能显著提高去势抵抗患者的存活率。

 

原始出处:

https://www.firstwordpharma.com/node/1784889?tsid=4

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    2021-02-12 bugit
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  5. 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content=这个好, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201102/8c4455ab759843818e1f3ed7cde78e76/6d4732742c8a41a4950d5048ba13560e.jpg, createdBy=38792245245, createdName=Terry tao, createdTime=Sun Dec 20 10:46:14 CST 2020, time=2020-12-20, status=1, ipAttribution=)]
    2020-12-23 江湖医侠

    真好

    0

  6. 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  7. 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content=癌细胞可转移到骨头和淋巴结等部位。前列腺癌早期可能没有症状,晚期可导致排尿困难、尿血、背痛、骨盆疼痛等症状。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Mon Dec 21 11:15:38 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040910, encodeId=5bfa104091054, 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=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Dec 20 13:26:57 CST 2020, time=2020-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909523, encodeId=b8af909523a8, content=这个好, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201102/8c4455ab759843818e1f3ed7cde78e76/6d4732742c8a41a4950d5048ba13560e.jpg, createdBy=38792245245, createdName=Terry tao, createdTime=Sun Dec 20 10:46:14 CST 2020, time=2020-12-20, status=1, ipAttribution=)]
  8. 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level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59813, encryptionId=86cf59813ad, topicName=晚期前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=776d2903072, createdName=zhyy89, createdTime=Tue Dec 22 01:26:57 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1511774, encodeId=07101511e74a0, content=<a href='/topic/show?id=90d75628960' target=_blank style='color:#2F92EE;'>#拮抗剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56289, encryptionId=90d75628960, topicName=拮抗剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=474c10379153, createdName=ms5236388012055669, createdTime=Tue Dec 22 01:26:57 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909719, encodeId=75f5909e1949, content=癌细胞可转移到骨头和淋巴结等部位。前列腺癌早期可能没有症状,晚期可导致排尿困难、尿血、背痛、骨盆疼痛等症状。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Mon Dec 21 11:15:38 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040910, encodeId=5bfa104091054, 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=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Dec 20 13:26:57 CST 2020, time=2020-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909523, encodeId=b8af909523a8, content=这个好, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201102/8c4455ab759843818e1f3ed7cde78e76/6d4732742c8a41a4950d5048ba13560e.jpg, createdBy=38792245245, createdName=Terry tao, createdTime=Sun Dec 20 10:46:14 CST 2020, time=2020-12-20, status=1, ipAttribution=)]
    2020-12-21 Jessie Zhang

    癌细胞可转移到骨头和淋巴结等部位。前列腺癌早期可能没有症状,晚期可导致排尿困难、尿血、背痛、骨盆疼痛等症状。

    0

  9. 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level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59813, encryptionId=86cf59813ad, topicName=晚期前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=776d2903072, createdName=zhyy89, createdTime=Tue Dec 22 01:26:57 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1511774, encodeId=07101511e74a0, content=<a href='/topic/show?id=90d75628960' target=_blank style='color:#2F92EE;'>#拮抗剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56289, encryptionId=90d75628960, topicName=拮抗剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=474c10379153, createdName=ms5236388012055669, createdTime=Tue Dec 22 01:26:57 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909719, encodeId=75f5909e1949, content=癌细胞可转移到骨头和淋巴结等部位。前列腺癌早期可能没有症状,晚期可导致排尿困难、尿血、背痛、骨盆疼痛等症状。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Mon Dec 21 11:15:38 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040910, encodeId=5bfa104091054, 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=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Dec 20 13:26:57 CST 2020, time=2020-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909523, encodeId=b8af909523a8, content=这个好, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201102/8c4455ab759843818e1f3ed7cde78e76/6d4732742c8a41a4950d5048ba13560e.jpg, createdBy=38792245245, createdName=Terry tao, createdTime=Sun Dec 20 10:46:14 CST 2020, time=2020-12-20, status=1, ipAttribution=)]
    2020-12-20 misszhang

    前列腺癌相关研究,学习了,谢谢梅斯

    0

  10. 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level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59813, encryptionId=86cf59813ad, topicName=晚期前列腺癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=776d2903072, createdName=zhyy89, createdTime=Tue Dec 22 01:26:57 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1511774, encodeId=07101511e74a0, content=<a href='/topic/show?id=90d75628960' target=_blank style='color:#2F92EE;'>#拮抗剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=56289, encryptionId=90d75628960, topicName=拮抗剂)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=474c10379153, createdName=ms5236388012055669, createdTime=Tue Dec 22 01:26:57 CST 2020, time=2020-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909719, encodeId=75f5909e1949, content=癌细胞可转移到骨头和淋巴结等部位。前列腺癌早期可能没有症状,晚期可导致排尿困难、尿血、背痛、骨盆疼痛等症状。, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201120/5008534db22c474a844fbd107ff83af2/d3e20fc133b542208ff15e7f2b575329.jpg, createdBy=c7015311102, createdName=Jessie Zhang, createdTime=Mon Dec 21 11:15:38 CST 2020, time=2020-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1040910, encodeId=5bfa104091054, 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=94, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=misszhang, createdTime=Sun Dec 20 13:26:57 CST 2020, time=2020-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909523, encodeId=b8af909523a8, content=这个好, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201102/8c4455ab759843818e1f3ed7cde78e76/6d4732742c8a41a4950d5048ba13560e.jpg, createdBy=38792245245, createdName=Terry tao, createdTime=Sun Dec 20 10:46:14 CST 2020, time=2020-12-20, status=1, ipAttribution=)]
    2020-12-20 Terry tao

    这个好

    0

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美国生物技术公司Tokai Pharmaceuticals去势抵抗前列腺癌药物Galeterone的一个叫做Armor3-SV三期临床因疗效被数据监察委员会提前终止。这个临床试验比较Galeterone与阿斯特拉/Medivation的雄激素受体拮抗剂Xtandi对转移前列腺癌患者无进展生存期的改善,结果Galeterone未能显示能超过Xtandi,试验因此被终止。Galeterone是Toka

研究者发现晚期前列腺癌个体化治疗的基因疗法

梅奥诊所个性化药物研究中心的研究人员发现了肿瘤抵抗治疗晚期前列腺癌的特效疗法的遗传学线索。这一发现可以指导医疗卫生人员对去势抵抗性前列腺癌进行个体化治疗,这是一种对标准激素治疗无效的致命疾病。美国食品和药物管理局批准了一些治疗去势抵抗性前列腺癌的疗法,但这些疗法对每个病人的疗效均不同。主研究员Manish Kohli医学博士和实验室合作研究人员Liewei Wang博士的新研究发现,遗传标记物可预

2019 APCCC报告:晚期前列腺癌患者的管理

晚期前列腺癌在治疗、影像学以及分子特征方面的创新改善了患者的预后,但仍有许多方面的管理缺乏高水平证据指导临床实践。2019年晚期前列腺共识会议(APCCC)讨论了一些晚期前列腺癌患者管理的主题,以补充基于1级证据的指导建议。

J Clin Oncol:晚期前列腺癌:基于正念的认知治疗有效吗?

其实此类研究的结果也很容易预测到,但如果国内想进行此类型的研究,开展是很难的。

美国FDA批准RV001治疗晚期前列腺癌的IIb期临床试验

RhoVac制药公司近日宣布,2020年2月28日,美国食品药品监督管理局(FDA)批准了RV001的研究性新药申请(IND),以启动RV001治疗晚期前列腺癌的IIb期临床试验。

PARP抑制剂Lynparza在BRCA突变的晚期前列腺癌男性中有效率达80%

一项新的临床试验显示,MSD和AstraZeneca的 PARP抑制剂Lynparza(olaparib)显示出可减缓或阻止特定类型晚期前列腺癌的生长。Lynparza在BRCA基因突变的80%以上的前列腺癌男性中有效。

拓展阅读

老药西地兰“焕发第二春”?强心小菜一碟,抗癌还有一手!

Cancers:强心苷西地兰通过调节多种信号通路在前列腺癌细胞中发挥抗癌活性

European Urology:热门靶点CD38在晚期前列腺癌中的作用

CD38可以协同和克服现有的腺苷合成经典靶向治疗的耐药性,并帮助患者选择合理的组合治疗方案。

美国FDA批准RV001治疗晚期前列腺癌的IIb期临床试验

RhoVac制药公司近日宣布,2020年2月28日,美国食品药品监督管理局(FDA)批准了RV001的研究性新药申请(IND),以启动RV001治疗晚期前列腺癌的IIb期临床试验。

2019 APCCC报告:晚期前列腺癌患者的管理

晚期前列腺癌在治疗、影像学以及分子特征方面的创新改善了患者的预后,但仍有许多方面的管理缺乏高水平证据指导临床实践。2019年晚期前列腺共识会议(APCCC)讨论了一些晚期前列腺癌患者管理的主题,以补充基于1级证据的指导建议。

PARP抑制剂Lynparza在BRCA突变的晚期前列腺癌男性中有效率达80%

一项新的临床试验显示,MSD和AstraZeneca的 PARP抑制剂Lynparza(olaparib)显示出可减缓或阻止特定类型晚期前列腺癌的生长。Lynparza在BRCA基因突变的80%以上的前列腺癌男性中有效。

研究者发现晚期前列腺癌个体化治疗的基因疗法

梅奥诊所个性化药物研究中心的研究人员发现了肿瘤抵抗治疗晚期前列腺癌的特效疗法的遗传学线索。这一发现可以指导医疗卫生人员对去势抵抗性前列腺癌进行个体化治疗,这是一种对标准激素治疗无效的致命疾病。美国食品和药物管理局批准了一些治疗去势抵抗性前列腺癌的疗法,但这些疗法对每个病人的疗效均不同。主研究员Manish Kohli医学博士和实验室合作研究人员Liewei Wang博士的新研究发现,遗传标记物可预

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