FDA突破性药物疗法认证：治疗罕见癌症新药pexidartinib

2015-11-03 佚名生物谷

日本著名药企第一三共最近宣布公司开发的新药pexidartinib已经获得了FDA的突破性药物疗法认证。这也标志着这种疗法将正式走上优先审批的道路。 Pexidartinib是一种用于治疗腱鞘巨细胞瘤（TGCT）的新药。腱鞘巨细胞瘤是一种罕见的腱鞘癌。目前临床上一般是通过手术切除的方法来治疗这种疾病，但是由于TGCT具有多个类型，并且一般发生在骨组织和关节处，因此使得临床上急需新的介入疗法的

日本著名药企第一三共最近宣布公司开发的新药pexidartinib已经获得了FDA的突破性药物疗法认证。这也标志着这种疗法将正式走上优先审批的道路。

Pexidartinib是一种用于治疗腱鞘巨细胞瘤（TGCT）的新药。腱鞘巨细胞瘤是一种罕见的腱鞘癌。目前临床上一般是通过手术切除的方法来治疗这种疾病，但是由于TGCT具有多个类型，并且一般发生在骨组织和关节处，因此使得临床上急需新的介入疗法的出现。今年三月份，第一三共制药公司招募了126名TGCT患者，开展了一项临床三期研究，以评估这一药物的实际效果。

此次，FDA授予pexidartinib突破性药物认证，主要是基于公司提供的验证性临床一期研究结果。在这项研究中科学家证明pexidartinib在TGCT治疗中有着良好效果，足以支持其直接进入临床三期研究。同时，第一三共还表示，此次突破性药物认证将提供一条与FDA管理人员直接沟通的路线，并能够在临床三期研究中与管理人员直接沟通。

Pexidartinib的前身为PLX3397，是Plexxikon公司旗下的研发药物。2011年，第一三共公司花费9亿3千5百万美元的价格收购了Plexxikon公司并将该药物收归旗下。而Plexxikon公司此前则是因为其开发的黑色素瘤药物vemurafenib而名声大噪。

作为日本有数的跨国医药公司，近几年来略显低调的第一三共公司一直处于转型阶段。公司此前有消息称将其在美国的公司裁员1200人，并将视线逐渐转移至罕见疾病的药物研发上面。而此次pexidartinib或许就是公司的试水之作。

原始出处：

Damian Garde.Daiichi Sankyo's cancer drug wins the FDA's coveted 'breakthrough' tag.FierceBiotech.Oct 30,2015

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2017-05-22 1e145228m78(暂无匿称)

学习了，谢谢作者分享!

113 0
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2016-02-24 flyingeagle77

#DART#

105 0
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2016-09-10 yb6560

#突破性药物#

73 0
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2016-07-13 feather89

#PE#

115 0
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2016-01-21 gostraight

#药物疗法#

93 0
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2015-11-05 zhaojie88

#ART#

74 0
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2015-11-05 syscxl

#罕见#

74 0
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2015-11-04 jetleo

很少见的肿瘤

221 0

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