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FDA批准Turalio(pexidartinib)治疗腱鞘巨细胞瘤

2019-08-04 Allan MedSci原创

美国FDA近日宣布,已批准Daiichi Sankyo的CSF1抑制剂Turalio(pexidartinib)用于治疗手术改善无效的成人症状性腱鞘巨细胞瘤(TGCT)。

美国FDA近日宣布,已批准Daiichi SankyoCSF1抑制剂Turaliopexidartinib)用于治疗手术改善无效的成人症状性腱鞘巨细胞瘤(TGCT)。FDA药物评估和研究中心血液学和肿瘤产品办公室主任Richard Pazdur说:手术是TGCT的主要治疗选择,但有些患者不符合手术条件,即使手术后肿瘤也会复发

这项批准是基于来自120名症状性晚期TGCT患者的随机IIIENLIVEN试验的数据,主要终点是治疗25周后的总反应率(ORR)。结果显示,Turalio治疗组的ORR达到了38%,显著高于安慰剂组。Turalio治疗组的CRPR率分别为15%和23%。


原始出处:

http://www.firstwordpharma.com/node/1656632#axzz5vaProhET

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    2019-12-14 feather89
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    2020-01-03 bugit
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    2019-08-05 zhaojie88
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  8. [GetPortalCommentsPageByObjectIdResponse(id=1728080, encodeId=10261e28080db, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=55, 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=Sat Dec 14 13:21:00 CST 2019, time=2019-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1993845, encodeId=7c8519938458a, content=<a href='/topic/show?id=fa27855193f' target=_blank style='color:#2F92EE;'>#腱鞘巨细胞瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=85519, encryptionId=fa27855193f, topicName=腱鞘巨细胞瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f4c124, createdName=neurowu, createdTime=Thu Nov 28 18:21:00 CST 2019, time=2019-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839706, encodeId=1c201839e06f0, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=80, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Jan 03 04:21:00 CST 2020, time=2020-01-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1936672, encodeId=9d2919366e2ba, content=<a href='/topic/show?id=db101e94685' target=_blank style='color:#2F92EE;'>#Turalio#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17946, encryptionId=db101e94685, topicName=Turalio)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/101173734/0EDD6BA8A8C6A0C23E8ABC8BA5331A25/100, createdBy=d37d2500154, createdName=ms5106640509429053, createdTime=Thu Jul 02 17:21:00 CST 2020, time=2020-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1784091, encodeId=ae0a1e840919c, content=<a href='/topic/show?id=5e1f5e0648' target=_blank style='color:#2F92EE;'>#DART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=5706, encryptionId=5e1f5e0648, topicName=DART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=9fe6351, createdName=flyingeagle77, createdTime=Thu Dec 05 07:21:00 CST 2019, time=2019-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357244, encodeId=329b135e244fd, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Mon Aug 05 23:21:00 CST 2019, time=2019-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476010, encodeId=085914e6010f9, content=<a href='/topic/show?id=2bcee797732' target=_blank style='color:#2F92EE;'>#细胞瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77977, encryptionId=2bcee797732, topicName=细胞瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf5e7252474, createdName=spoonycyy, createdTime=Mon Aug 05 23:21:00 CST 2019, time=2019-08-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1502260, encodeId=35601502260d6, content=<a href='/topic/show?id=021d4821096' target=_blank style='color:#2F92EE;'>#巨细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48210, encryptionId=021d4821096, topicName=巨细胞)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=11759518880, createdName=wwzzly, createdTime=Mon Aug 05 23:21:00 CST 2019, time=2019-08-05, status=1, ipAttribution=)]
    2019-08-05 wwzzly
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