罗氏的PD-L1单抗获优先审评权,有望今年9月获批上市

2016-03-21 佚名 生物谷

FDA对膀胱癌治疗单抗药物atezolizumab的审评开绿灯,罗氏有望在今年秋季拿到新药批文。 罗氏在声明中说,FDA监察员已经接受了公司的BLA申请,并且表示会对atezolizumab用于治疗膀胱癌某些患者的申请进行优先审批。据悉,本药在2014年曾被授予突破性药物(breakthrough therapy)状态。 具体来说,罗氏此

FDA对膀胱癌治疗单抗药物atezolizumab的审评开绿灯,罗氏有望在今年秋季拿到新药批文。

罗氏在声明中说,FDA监察员已经接受了公司的BLA申请,并且表示会对atezolizumab用于治疗膀胱癌某些患者的申请进行优先审批。据悉,本药在2014年曾被授予突破性药物(breakthrough therapy)状态。

具体来说,罗氏此次的预期适应症人群为:局限性晚期或者出现转移的膀胱上皮癌患者——这些患者在进行铂类药物化疗中或化疗后,病情进一步恶化,或者在手术前后接受了铂类药物化疗的一年内,病情出现恶化。

膀胱上皮癌患者占膀胱癌患者的90%,在肾盂、输尿管及尿道中也会发生相应病变。

目前,除了化疗药以外,上市的治疗药物仍然非常有限——尽管目前诺华、默沙东和艾尔健公司的很多药物都在试图进入该领域。

FDA对优先审评的授予是有条件的,不是药物针对的疾病的上市药物种类非常有限,就是该药的疗效非常显着。一旦授予优先审评权,FDA就会加快审评速度,将审评时间缩短到6个月——也就是说,在9月12日之前对是否批准atezolizumab上市给出最终答复。

该药的最新临床研究——处于II期,开放标签IMvigor 210研究——显示,接受铂类药物化疗之后病情恶化的310名患者,在接受atezolizumab治疗之后,经过平均11.7个月的随访,仍然有15%患者的肿瘤体积小于治疗前。

另外,在中度或者高度表达PD-L1的100名患者中,接受atezolizumab治疗后,26%患者的肿瘤体积缩小了。本药物是由罗氏公司所属的基因泰克开发的。

罗氏希望成为第一个将PD-L1免疫疗法用于治疗膀胱内膜癌的公司。

不过,放在更大的PD-1(programmed death-1,即程序性死亡蛋白-1)和PD-L1(programmed death ligand-1,即程序性死亡蛋白受体-1)领域,这个事件就只是罗氏公司追赶其他公司进度的一个事件了。百时美施贵宝公司和默沙东公司的PD-1药物Opdivo和Keytruda,在2014年已经领先一步获得FDA批准,用于黑色素瘤的治疗。

另外,罗氏不是唯一一个抓紧时间进行PD-1和PD-L1药物开发的公司。和罗氏争夺成为该领域第三个具有获批该类药物的对手,是阿斯利康。当然,罗氏的药物针对PD-L1为靶点,与目前获批的2个药物均针对PD-1靶点不同。atezolizumab通过直接结合到肿瘤细胞或者肿瘤浸润免疫细胞表达的PD-L1发挥治疗作用。

罗氏打赌,这种新的作用机制,将会使atezolizumab有别于其他药物,而且长期疗效更好。

另外,默沙东正在某些表达PD-L1的膀胱癌患者中,检验Keytruda的疗效——这也意味着,如果这两个药物都能够获批,罗氏在膀胱癌治疗领域将会马上有竞争者。

2016年,预计超过76000名美国人被诊断为膀胱癌,其中,大约11%的患者,在确诊时即进展到癌症后期。

预计在10年后,PD-1和PD-L1市场将达到300亿美元左右;而且由于Opdivo将会获批用于更多癌症,其所属公司百时美施贵宝的市场份额将会达到与60亿美元。

atezolizumab和安进公司的肿瘤免疫治疗药物Imlygic的联合用药方案,目前在三阴性乳腺癌患者和出现肝转移的结直肠癌中进行I期临床试验。atezolizumab在高表达PD-L1的非小细胞肺癌患者的生存数据也已经公布;针对某些肾脏癌症患者的疗效评价的临床试验,也已经开始。

基于罗氏在atezolizumab临床试验方面的努力和目前的实验结果,罗氏希望该药能够在未来10年内逐渐成为一个重磅炸弹级药物,维持公司的销售态势,使阿瓦斯汀和利妥昔的专利悬崖到来之后,即使面对蜂拥而至的生物类似药的威胁,公司仍然能够从容应对。

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    2018-01-28 1e145228m78(暂无匿称)

    学习了谢谢作者分享!

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    2016-07-19 weiz
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    2016-03-25 心流

    可惜不能用于肝癌,因为大多数肝癌都是乙肝背景

    0

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    2016-03-23 jetleo

    atezolizumab通过直接结合到肿瘤细胞或者肿瘤浸润免疫细胞表达的PD-L1发挥治疗作用。

    0

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    2016-03-23 jetleo

    罗氏的药物针对PD-L1为靶点,与目前获批的2个药物均针对PD-1靶点不同。atezolizumab通过直接结合到肿瘤细胞或者肿瘤浸润免疫细胞表达的PD-L1发挥治疗作用。

    0

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    2016-03-23 smartjoy
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  9. [GetPortalCommentsPageByObjectIdResponse(id=282707, encodeId=6545282e07c4, content=学习了谢谢作者分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3xJXLtMtt5B40XXuPjn9xn1rBhrM6fHLkX1hI86ZoWoPJkgDkZuJNKkBfBHOcRd1fAdezg7JlHNOokohdAp3WkI/0, createdBy=32c81964262, createdName=1e145228m78(暂无匿称), createdTime=Sun Jan 28 00:12:11 CST 2018, time=2018-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1632535, encodeId=548216325358a, content=<a href='/topic/show?id=aa0488034a0' target=_blank style='color:#2F92EE;'>#获批上市#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88034, encryptionId=aa0488034a0, topicName=获批上市)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=820f21933891, createdName=weiz, createdTime=Tue Jul 19 09:04:00 CST 2016, time=2016-07-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1634747, encodeId=e2ba1634e47fc, content=<a href='/topic/show?id=6da725e314e' target=_blank style='color:#2F92EE;'>#优先审评#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25731, encryptionId=6da725e314e, topicName=优先审评)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=4be222283241, createdName=ms5822920152752585, createdTime=Wed Aug 24 12:04:00 CST 2016, time=2016-08-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73751, encodeId=1976e3751f8, content=可惜不能用于肝癌,因为大多数肝癌都是乙肝背景, beContent=null, objectType=article, channel=null, level=null, likeNumber=127, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=738d1704566, createdName=心流, createdTime=Fri Mar 25 16:00:00 CST 2016, time=2016-03-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=72969, encodeId=49c3e2969ba, content=atezolizumab通过直接结合到肿瘤细胞或者肿瘤浸润免疫细胞表达的PD-L1发挥治疗作用。, beContent=null, objectType=article, channel=null, level=null, likeNumber=136, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Wed Mar 23 16:27:00 CST 2016, time=2016-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=72966, encodeId=c1cee29667d, content=罗氏的药物针对PD-L1为靶点,与目前获批的2个药物均针对PD-1靶点不同。atezolizumab通过直接结合到肿瘤细胞或者肿瘤浸润免疫细胞表达的PD-L1发挥治疗作用。, beContent=null, objectType=article, channel=null, level=null, likeNumber=118, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Wed Mar 23 16:18:00 CST 2016, time=2016-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1254888, encodeId=7ccc12548887c, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Wed Mar 23 04:04:00 CST 2016, time=2016-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1538951, encodeId=f4e81538951b3, content=<a href='/topic/show?id=349913924d1' target=_blank style='color:#2F92EE;'>#PD-L1单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13924, encryptionId=349913924d1, topicName=PD-L1单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=195c13086613, createdName=ylz8407, createdTime=Wed Mar 23 04:04:00 CST 2016, time=2016-03-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=72636, encodeId=0425e2636b8, content=好好学习,加深理解, beContent=null, objectType=article, channel=null, level=null, likeNumber=171, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Tue Mar 22 12:26:00 CST 2016, time=2016-03-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=72637, encodeId=d735e2637ee, content=好好学习,加深理解, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Tue Mar 22 12:26:00 CST 2016, time=2016-03-22, status=1, ipAttribution=)]
    2016-03-22 忠诚向上

    好好学习,加深理解

    0

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    2016-03-22 忠诚向上

    好好学习,加深理解

    0

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