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武田多发性骨髓瘤药物ixazomib三期临床显示预期疗效

2015-02-12 佚名 美中药源

今天武田多发性骨髓瘤药物ixazomib在一个三期临床的中期分析中显示预期疗效。在这个722人的临床试验中,复发性骨髓瘤病人使用来那度胺/地塞米松加ixazomib比加安慰剂的无进展生存期更长,但具体数据没有公布。武田准备用这个实验结果申请上市。 Ixazomib是武田重磅药物硼替佐米的类似物,是第一个口服蛋白酶体抑制剂,也是武田最重要的抗癌在研药物。Ixazomib是一个前药,结构和硼替佐米十

今天武田多发性骨髓瘤药物ixazomib在一个三期临床的中期分析中显示预期疗效。在这个722人的临床试验中,复发性骨髓瘤病人使用来那度胺/地塞米松加ixazomib比加安慰剂的无进展生存期更长,但具体数据没有公布。武田准备用这个实验结果申请上市。

Ixazomib是武田重磅药物硼替佐米的类似物,是第一个口服蛋白酶体抑制剂,也是武田最重要的抗癌在研药物。Ixazomib是一个前药,结构和硼替佐米十分类似,安进也有一个蛋白酶体抑制剂carfilzomib已经上市。多发性骨髓瘤主要是沙利度胺类似物和蛋白酶体抑制剂的天下,最近没有什么新的治疗方法。Ixazomib从结构上看不可能是个颠覆性药物,能获得FDA突破性药物有点令人匪夷所思。

硼替佐米是原来Millennium所开发上市,2010年Millennium被武田以88亿美元收购,成为武田的抗癌药分部。武田当年靠me-too质子泵抑制剂和PPAR糖尿病药物起家,但近年来总走背字。其DPP4抑制剂alogliptin成为2008年FDA新政策的第一个牺牲品,被延误了5年。去年因为Actos的事被一法官判罚90亿罚金但最后只罚了个零头。另一个Millennium药物orteronel去年在前列腺癌实验中失败,和Orexigen的减肥药合作也和其它减肥产品一样站在贼船上骑虎难下。

蛋白酶体抑制剂是个独特的抗癌策略。细胞每天要更新5-7%的蛋白质,这需要蛋白酶体的参与。如果蛋白酶体功能受阻,很多需要降解的蛋白不能及时清除则会造成细胞死亡。但遗憾的是这类药物目前只在多发性骨髓瘤有足够的治疗窗口,在更广泛的实体瘤基本无效。根据其结构和硼替佐米的类似程度以及机理的局限性如果Ixazomib只限于末期病人其商业价值将有一定限。但如果想成为一线、二线用药,则必须得战胜来那度胺哥三以及两个已经上市的同类药物。这局面可用一句老歌歌词形容:面对我眼前的人群,我得通过而且潇洒。但其口服给药可能会成为病人选择这个产品的重要动力,支付部门能否支持则是另一个问题.

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  2. [GetPortalCommentsPageByObjectIdResponse(id=1714713, encodeId=fca11e14713a6, content=<a href='/topic/show?id=021230e312' target=_blank style='color:#2F92EE;'>#AZ#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3073, encryptionId=021230e312, topicName=AZ)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=9e5031899089, createdName=12498e5fm22(暂无昵称), createdTime=Thu Mar 26 00:23:00 CST 2015, time=2015-03-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1889618, encodeId=a4ec188961889, content=<a href='/topic/show?id=760c430895a' target=_blank style='color:#2F92EE;'>#多发性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=43089, encryptionId=760c430895a, topicName=多发性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04d6114, createdName=jml2009, createdTime=Sat Aug 22 04:23:00 CST 2015, time=2015-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1991297, encodeId=c8ef199129e73, content=<a href='/topic/show?id=5bd3196e127' target=_blank style='color:#2F92EE;'>#三期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19671, encryptionId=5bd3196e127, topicName=三期临床)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9ed371, createdName=楚秀娟, createdTime=Sat Jun 20 08:23:00 CST 2015, time=2015-06-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=15727, encodeId=760515e27d1, content=以阅, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c68e1614119, createdName=windmilL1989, createdTime=Mon Feb 16 13:53:00 CST 2015, time=2015-02-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517225, encodeId=4322151e22548, content=<a href='/topic/show?id=a0176333892' target=_blank style='color:#2F92EE;'>#武田#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63338, encryptionId=a0176333892, topicName=武田)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f6da11069119, createdName=12498f17m69暂无昵称, createdTime=Sat Feb 14 00:23:00 CST 2015, time=2015-02-14, status=1, ipAttribution=)]
    2015-08-22 jml2009
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    2015-02-16 windmilL1989

    以阅

    0

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