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Seattle Genetics/Astellas的抗体-药物偶联物Padcev治疗晚期尿路上皮癌,获得FDA批准

2019-12-21 不详 MedSci原创

Astellas和Seattle Genetics宣布FDA加快了对Padcev(enfortumab vedotin-ejfv)的批准,用于治疗部分局部晚期或转移性尿路上皮癌的成年患者。具体来说,该靶向Nectin-4的抗体-药物偶联物(ADC)被指定用于先前在手术前后接受过PD-1/L1抑制剂和含铂化疗后局部晚期或转移性的患者。

Astellas和Seattle Genetics宣布FDA加快了对Padcev(enfortumab vedotin-ejfv)的批准,用于治疗部分局部晚期或转移性尿路上皮癌的成年患者。具体来说,该靶向Nectin-4的抗体-药物偶联物(ADC)被指定用于先前在手术前后接受过PD-1/L1抑制剂和含铂化疗后局部晚期或转移性的患者。

根据两家公司的说法,Padcev是首个针对该类患者获得FDA批准的治疗药物。

该药物的批准是基于EV-201研究的结果,该研究招募了125例PD-1或PD-L1抑制剂和含铂化疗后局部晚期或转移性尿道上皮癌患者。在该试验中,总缓解率为44%,其中12%的患者具有完全缓解,32%的患者具有部分缓解。中位反应时间为7.6个月。

Astellas和Seattle Genetics目前正在进行一项名为EV-301的III期验证试验,该试验还旨在支持Padcev的全球注册。

原始出处:


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    2020-10-19 canlab
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440246, encodeId=58e114402464b, content=<a href='/topic/show?id=89795982594' target=_blank style='color:#2F92EE;'>#晚期尿路上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59825, encryptionId=89795982594, topicName=晚期尿路上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36294710956, createdName=1249894fm74暂无昵称, createdTime=Mon Dec 23 03:19:00 CST 2019, time=2019-12-23, status=1, ipAttribution=)]
    2020-01-29 cy0324
  5. 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  6. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440246, encodeId=58e114402464b, content=<a href='/topic/show?id=89795982594' target=_blank style='color:#2F92EE;'>#晚期尿路上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59825, encryptionId=89795982594, topicName=晚期尿路上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36294710956, createdName=1249894fm74暂无昵称, createdTime=Mon Dec 23 03:19:00 CST 2019, time=2019-12-23, status=1, ipAttribution=)]
    2020-02-15 tm10051981
  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440246, encodeId=58e114402464b, content=<a href='/topic/show?id=89795982594' target=_blank style='color:#2F92EE;'>#晚期尿路上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59825, encryptionId=89795982594, topicName=晚期尿路上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36294710956, createdName=1249894fm74暂无昵称, createdTime=Mon Dec 23 03:19:00 CST 2019, time=2019-12-23, status=1, ipAttribution=)]
    2020-01-27 bugit
  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440246, encodeId=58e114402464b, content=<a href='/topic/show?id=89795982594' target=_blank style='color:#2F92EE;'>#晚期尿路上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59825, encryptionId=89795982594, topicName=晚期尿路上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36294710956, createdName=1249894fm74暂无昵称, createdTime=Mon Dec 23 03:19:00 CST 2019, time=2019-12-23, status=1, ipAttribution=)]
    2020-04-05 仁医06
  9. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1440246, encodeId=58e114402464b, content=<a href='/topic/show?id=89795982594' target=_blank style='color:#2F92EE;'>#晚期尿路上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59825, encryptionId=89795982594, topicName=晚期尿路上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36294710956, createdName=1249894fm74暂无昵称, createdTime=Mon Dec 23 03:19:00 CST 2019, time=2019-12-23, status=1, ipAttribution=)]
    2020-06-26 huperzia
  10. 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