Seattle Genetics和Astellas的抗体偶联药物enfortumab vedotin治疗局部晚期或转移性尿路上皮癌,喜获FDA的优先审查

2019-09-17 不详 MedSci原创

Seattle Genetics和Astellas Pharma(安斯泰来)宣布,美国食品和药物管理局(FDA)已接受其抗体偶联药物enfortumab vedotin的生物制剂许可申请(BLA)并授予优先审查治疗局部晚期或转移性尿路上皮癌患者,这些患者已接受PD-1 / L1抑制剂,并且在新辅助/辅助,局部晚期或转移性环境中接受含铂化疗。

Seattle Genetics和Astellas Pharma(安斯泰来)宣布,美国食品和药物管理局(FDA)已接受其抗体偶联药物enfortumab vedotin的生物制剂许可申请(BLA)并授予优先审查治疗局部晚期或转移性尿路上皮癌患者,这些患者已接受PD-1 / L1抑制剂,并且在新辅助/辅助,局部晚期或转移性环境中接受含铂化疗。

Enfortumab vedotin是一种研究性抗体药物偶联物(ADC),由靶向Nectin-4的人IgG1单克隆抗体enfortumab与细胞毒药物MMAE(monomethyl auristatin E,单甲基奥瑞他汀E,一种微管破坏剂)偶联而成。Nectin-4是一种在包括尿路上皮癌(UC)在内的多种实体肿瘤中高度表达的治疗靶标。

该申请基于EV-201关键2期临床试验中第一批患者的结果,这些患者于2019年6月在美国临床肿瘤学会(ASCO)年会上作为最新口头报告呈现。

FDA于2018年3月授予enfortumab vedotin突破疗法称号,用于检查点抑制剂治疗期间或之后疾病进展的局部晚期或转移性尿路上皮癌患者。

原始出处:

http://www.firstwordpharma.com/node/1666484?tsid=4#axzz5zl4ZRpZp

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replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7943, encryptionId=5d80e943ef, topicName=Genetics)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca89104, createdName=huperzia, createdTime=Fri Nov 01 09:42:00 CST 2019, time=2019-11-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1686308, encodeId=96d816863083a, content=<a href='/topic/show?id=66f3e93862' target=_blank style='color:#2F92EE;'>#Genet#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7938, encryptionId=66f3e93862, topicName=Genet)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d3e128296421, createdName=江川靖瑶, createdTime=Mon Aug 24 03:42:00 CST 2020, time=2020-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1734170, encodeId=e4491e3417075, content=<a href='/topic/show?id=d4f412668a4' target=_blank style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Sat Jan 11 15:42:00 CST 2020, time=2020-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912211, encodeId=4f9a191221196, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Aug 03 19:42:00 CST 2020, time=2020-08-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1954082, encodeId=7c0f19540827c, content=<a href='/topic/show?id=163116089c7' target=_blank style='color:#2F92EE;'>#Seattle#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16089, encryptionId=163116089c7, topicName=Seattle)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Tue Dec 17 02:42:00 CST 2019, time=2019-12-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2049227, encodeId=79dc204922eed, content=<a href='/topic/show?id=4363e929ad' target=_blank style='color:#2F92EE;'>#Gene#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7929, encryptionId=4363e929ad, topicName=Gene)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=63a4277, createdName=cy0324, createdTime=Sat Jan 25 15:42:00 CST 2020, time=2020-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650761, encodeId=f2e81650e61c8, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue Dec 10 04:42:00 CST 2019, time=2019-12-10, status=1, ipAttribution=)]
    2019-11-01 huperzia
  5. [GetPortalCommentsPageByObjectIdResponse(id=1700456, encodeId=79d31e0045698, content=<a href='/topic/show?id=a3094e618fc' target=_blank style='color:#2F92EE;'>#局部晚期或转移性尿路上皮癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47618, encryptionId=a3094e618fc, topicName=局部晚期或转移性尿路上皮癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=905730099938, createdName=dinorsor534, createdTime=Wed Aug 12 15:42:00 CST 2020, time=2020-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1712094, encodeId=972e1e120946a, content=<a href='/topic/show?id=9a1c289680' target=_blank style='color:#2F92EE;'>#AST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2896, encryptionId=9a1c289680, topicName=AST)], attachment=null, authenticateStatus=null, 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  6. 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style='color:#2F92EE;'>#NET#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12668, encryptionId=d4f412668a4, topicName=NET)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7ea033781210, createdName=canlab, createdTime=Sat Jan 11 15:42:00 CST 2020, time=2020-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912211, encodeId=4f9a191221196, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=17, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Aug 03 19:42:00 CST 2020, time=2020-08-03, status=1, ipAttribution=), 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createdName=cy0324, createdTime=Sat Jan 25 15:42:00 CST 2020, time=2020-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650761, encodeId=f2e81650e61c8, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue Dec 10 04:42:00 CST 2019, time=2019-12-10, status=1, ipAttribution=)]
    2020-01-11 canlab
  7. 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createdName=cy0324, createdTime=Sat Jan 25 15:42:00 CST 2020, time=2020-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650761, encodeId=f2e81650e61c8, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue Dec 10 04:42:00 CST 2019, time=2019-12-10, status=1, ipAttribution=)]
    2020-08-03 snf701207
  8. 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createdName=cy0324, createdTime=Sat Jan 25 15:42:00 CST 2020, time=2020-01-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1650761, encodeId=f2e81650e61c8, content=<a href='/topic/show?id=ffae4e614b6' target=_blank style='color:#2F92EE;'>#局部晚期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=47614, encryptionId=ffae4e614b6, topicName=局部晚期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=901d24099859, createdName=yhy100208, createdTime=Tue Dec 10 04:42:00 CST 2019, time=2019-12-10, status=1, ipAttribution=)]
    2019-12-17 仁医06
  9. 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    2020-01-25 cy0324
  10. 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