成纤维细胞生长因子受体(FGFR)抑制剂pemigatinib治疗胆管癌获得FDA的优先审查

2019-12-03 不详 MedSci原创

Incyte公司的Pemigatinib用于先前治疗过的局部晚期或转移性胆管癌,已被美国食品和药物管理局(FDA)授予优先审查。

Incyte公司的Pemigatinib用于先前治疗过的局部晚期或转移性胆管癌,已被美国食品和药物管理局(FDA)授予优先审查。

一项II期研究评估了Pemigatinib作为成纤维细胞生长因子受体(FGFR)抑制剂在先前接受过治疗的局部晚期或转移性胆管癌成人患者中的安全性和有效性。

FGFR在肿瘤细胞的增殖、存活、迁移和血管生成中起重要作用。FGFRs中的激活融合、重排、易位和基因扩增与各种癌症的发生密切相关。

接受Pemigatinib治疗的FGFR2融合或重排患者的总体缓解率为36%,中位缓解时间为七个半月,符合其主要终点和次要终点。任何不良事件也是可以控制的。

Pemigatinib是一种有效的,选择性的,口服FGFR同型一,二和三的抑制剂。在临床前研究中,它已显示出针对具有FGFR变化癌细胞的选择性药理活性。FDA授予pemigatinib突破性疗法称号,用于治疗先前治疗过的,晚期/转移性或不可切除的FGFR2易位性胆管癌。

Pemigatinib用于治疗胆管癌被FDA授予了孤儿药物指定(ODD)。

该制药公司正在进行的II和III期研究中,对Pemigatinib治疗各种FGFR驱动的癌症(包括转移性或不可手术的膀胱癌,具有FGFR1融合和重排的骨髓增生性肿瘤以及先前已治疗且无法手术的具有FGFR突变的实体恶性肿瘤)的安全性和有效性。

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    2020-06-07 jklm09
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beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14030, encryptionId=a8861403017, topicName=pemigatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca282500032, createdName=1249857fm32暂无昵称, createdTime=Thu Dec 05 01:08:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400145, encodeId=0f85140014589, 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=27, 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=Thu Dec 05 01:08:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), 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createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Thu Dec 05 01:08:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503936, encodeId=bcc11503936fe, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9477, encryptionId=641d94e7eb, topicName=IgA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c23f9697922, createdName=yibei, createdTime=Thu Dec 05 01:08:00 CST 2019, time=2019-12-05, status=1, ipAttribution=)]
    2020-09-01 feather89
  5. 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  6. 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  7. 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    2019-12-05 yibei

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