FDA将优先审查Incyte的FGFR抑制剂pemigatinib以治疗胆管癌

2019-11-28 Allan MedSci原创

Incyte近日宣布,FDA将优先审查pemigatinib的市场应用,以作为某些胆管癌患者的潜在疗法。 Incyte靶向治疗负责人Peter Langmuir表示:“一线化疗以外的治疗选择有限,如果pemigatinib获得批准,选择性FGFR抑制剂将成为二线治疗的首选治疗方法”。

Incyte近日宣布,FDA将优先审查pemigatinib的市场应用,以作为某些胆管癌患者的潜在疗法。 Incyte靶向治疗负责人Peter Langmuir表示:一线化疗以外的治疗选择有限,如果pemigatinib获得批准,选择性FGFR抑制剂将成为二线治疗的首选治疗方法

这项决定得到了IIFIGHT-202研究的支持。140例先前经过治疗的、局部晚期或转移性胆管癌的成年患者入组。参与者被划分为三个队列:具有FGFR2融合或重排(队列A)、其他FGF / FGFR基因改变(队列B)、无FGF / FGFR遗传改变(队列C)。所有患者均在21天的周期内每天口服一次pemigatinib,直到疾病进展或不可接受的毒性。主要终点是队列A的总体缓解率(ORR)。


原始出处:

http://www.firstwordpharma.com/node/1683736#axzz66Wm9oxrD

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    2020-08-24 jklm09
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    2020-01-03 feather89
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encryptionId=a8861403017, topicName=pemigatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca282500032, createdName=1249857fm32暂无昵称, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400143, encodeId=d17c14001434f, 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=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1439318, encodeId=ef851439318c7, content=<a href='/topic/show?id=7f269824dc' target=_blank style='color:#2F92EE;'>#Incyte#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9824, encryptionId=7f269824dc, topicName=Incyte)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483067, encodeId=09a1148306eaa, content=<a href='/topic/show?id=5dcbe397d2' target=_blank style='color:#2F92EE;'>#FGFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7397, encryptionId=5dcbe397d2, topicName=FGFR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503935, encodeId=7cfb15039356f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534468, encodeId=2e021534468b3, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, 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  5. 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createdName=zz12341234, createdTime=Tue Mar 17 04:38:00 CST 2020, time=2020-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728210, encodeId=9a0c1e28210d4, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Fri Jan 03 15:38:00 CST 2020, time=2020-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1329848, encodeId=b8ed132984889, content=<a href='/topic/show?id=a8861403017' target=_blank style='color:#2F92EE;'>#pemigatinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400143, encodeId=d17c14001434f, 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=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1439318, encodeId=ef851439318c7, content=<a href='/topic/show?id=7f269824dc' target=_blank style='color:#2F92EE;'>#Incyte#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9824, encryptionId=7f269824dc, topicName=Incyte)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483067, encodeId=09a1148306eaa, content=<a href='/topic/show?id=5dcbe397d2' target=_blank style='color:#2F92EE;'>#FGFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7397, encryptionId=5dcbe397d2, topicName=FGFR)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503935, encodeId=7cfb15039356f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534468, encodeId=2e021534468b3, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1628405, encodeId=53d716284055d, content=<a href='/topic/show?id=9a4e83503e4' target=_blank style='color:#2F92EE;'>#胆管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83503, encryptionId=9a4e83503e4, topicName=胆管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c21721182790, createdName=cmj15wellington, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=)]
  6. 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authenticateStatus=null, createdAvatar=, createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503935, encodeId=7cfb15039356f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534468, encodeId=2e021534468b3, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1628405, encodeId=53d716284055d, content=<a href='/topic/show?id=9a4e83503e4' target=_blank style='color:#2F92EE;'>#胆管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83503, encryptionId=9a4e83503e4, topicName=胆管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c21721182790, createdName=cmj15wellington, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=)]
    2019-11-29 zhouqu_8
  7. 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encryptionId=a8861403017, topicName=pemigatinib)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca282500032, createdName=1249857fm32暂无昵称, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400143, encodeId=d17c14001434f, 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=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1439318, encodeId=ef851439318c7, content=<a href='/topic/show?id=7f269824dc' target=_blank style='color:#2F92EE;'>#Incyte#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9824, encryptionId=7f269824dc, topicName=Incyte)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1483067, encodeId=09a1148306eaa, content=<a href='/topic/show?id=5dcbe397d2' target=_blank style='color:#2F92EE;'>#FGFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7397, encryptionId=5dcbe397d2, topicName=FGFR)], attachment=null, 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  8. [GetPortalCommentsPageByObjectIdResponse(id=1852191, encodeId=30b61852191de, 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=27, 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=Mon Aug 24 16:38:00 CST 2020, time=2020-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1934056, encodeId=386819340563f, content=<a href='/topic/show?id=b942e405c4' target=_blank style='color:#2F92EE;'>#FGFR抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7405, encryptionId=b942e405c4, topicName=FGFR抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62e4433, 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authenticateStatus=null, createdAvatar=, createdBy=31fb7872570, createdName=12498c24m71暂无昵称, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1503935, encodeId=7cfb15039356f, content=<a href='/topic/show?id=641d94e7eb' target=_blank style='color:#2F92EE;'>#IgA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, 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=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534468, encodeId=2e021534468b3, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1628405, encodeId=53d716284055d, content=<a href='/topic/show?id=9a4e83503e4' target=_blank style='color:#2F92EE;'>#胆管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83503, encryptionId=9a4e83503e4, topicName=胆管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c21721182790, createdName=cmj15wellington, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=)]
    2019-11-29 yibei
  9. 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topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1628405, encodeId=53d716284055d, content=<a href='/topic/show?id=9a4e83503e4' target=_blank style='color:#2F92EE;'>#胆管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=83503, encryptionId=9a4e83503e4, topicName=胆管)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c21721182790, createdName=cmj15wellington, createdTime=Fri Nov 29 23:38:00 CST 2019, time=2019-11-29, status=1, ipAttribution=)]
    2019-11-29 liuyiping
  10. 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