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CFDA批准上市泰瑞沙®（甲磺酸奥希替尼片）审评概述，用于非小细胞性肺癌(NSCLC)成人患者的治疗

2017-12-01 新浪医药 新浪医药

非小细胞性肺癌泰瑞沙®
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2017年3月24日宣布，国家食品药品监督管理总局(CFDA)已正式批准第三代肺癌靶向药物泰瑞沙（甲磺酸奥希替尼片， AZD9291）用于既往经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现的疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞性肺癌(NSCLC)成人患者的治疗。推荐的剂量为80mg每日一次，根据患者个体的安全性和耐受性可进行


2017年3月24日宣布，国家食品药品监督管理总局(CFDA)已正式批准第三代肺癌靶向药物泰瑞沙（甲磺酸奥希替尼片， AZD9291）用于既往经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗时或治疗后出现的疾病进展，并且经检测确认存在EGFR T790M突变阳性的局部晚期或转移性非小细胞性肺癌(NSCLC)成人患者的治疗。推荐的剂量为80mg每日一次，根据患者个体的安全性和耐受性可进行剂量调整。

EGFR-TKI继发性耐药涉及多个作用机制，其中50%左右患者是由于产生T790M位点的突变，此作用机制被认为是此类治疗耐药性出现的主要途径。

甲磺酸奥希替尼片是一种口服、强效、选择性、不可逆的第三代EGFR-TKI，能够有效作用于EGFRm(TKI敏感性相关突变)和EGFR T790M突变阳性(TKI耐药性相关突变)形式的EGFR，且对野生型EGFR的活性很低。从而克服T790M耐药性机制，成为一线治疗失败后的具有T790M突变患者的治疗选择。

支持本品上市的主要依据为全球注册的关键II期AURA扩展研究和AURA2研究，以及在中国开展的一项Ⅰ期药理学AURA18研究和一项中国主导的II期AURA17研究。

AURA扩展研究和AURA2研究均为在接受至少1种EGFR-TKI治疗期间或治疗后出现疾病进展的局部晚期或转移性EGFR T790M突变阳性NSCLC经治患者评价甲磺酸奥希替尼片 80 mg每日一次治疗的安全性、药代动力学和疗效的开放性、单臂、II期研究。结果表明，自第二个数据截止日期（AURA扩展研究和AURA 2研究中位随访时间分别为6.9和6.7个月），两项研究汇总（N=411）的ORR为66.1%，盲态独立中心审查(BICR)及研究者评估以及缓解分析集与全分析集的主要可评价患者均测得一致性高客观缓解率。次要疗效指标 疾病控制率（DCR）为91%，中位PFS为9.7个月（38.7%成熟度）。

AURA 17研究作为中国主导的II期研究，是以全球II期研究为参考而设计，但其仅招募亚太地区患者，其中中国患者(148/171[86.5%]例)。以证实中国患者及全球患者之间的数据具有一致性。在数据截至日期 （中位随访时间4.2个月），研究（N=171）的ORR为60.2%，其中中国亚组的ORR为59.7%。次要疗效指标DCR为88%，中位PFS还未达到。以上疗效数据与全球II期研究结果高度一致。

AURA18研究(n=31)是一项在既往接受了已批准上市的EGFR-TKI(接受或未接受其他化疗方案)治疗后疾病进展的局部晚期或转移性NSCLC中国患者中开展的I期，开放性研究，该项研究考察了口服甲磺酸奥希替尼片在两个给药剂量(40 mg和80 mg)的药代动力学特征。药代动力学结果显示，奥希替尼单次给药后的PK参数与欧美人群相当。同亚洲以及非亚洲患者比较，中国患者口服奥希替尼药代动力学特征与其相似，奥希替尼的暴露量不受种族因素的影响。

安全性方面，AURA 17的安全性数据与全球II期安全性数据一致。绝大多数不良反应的严重程度为1或2级。最常报告的ADR有：腹泻(29%)和皮疹(20%)。与全球II期研究相比，AURA17中CTCAE≥3度不良事件的总发生率更低(24/171例[14.0%] vs 121/411例[29.4%])。

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    2017-12-21 bugit

    #FDA批准#

    0

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    2018-01-24 lingaifan

    #非小细胞#

    0

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    2017-12-09 stfoxst

    #CFDA#

    0

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    2018-09-22 zhaojie88

    #细胞性#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1839557, encodeId=4fec183955e89, 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=31, 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=Thu Dec 21 09:35:00 CST 2017, time=2017-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059671, encodeId=b69920596e1f7, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Wed Jan 24 07:35:00 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890679, encodeId=755918906e91d, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Sat Dec 09 08:35:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805135, encodeId=83ea180513566, content=<a href='/topic/show?id=3138e790655' target=_blank style='color:#2F92EE;'>#细胞性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77906, encryptionId=3138e790655, topicName=细胞性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Sep 22 15:35:00 CST 2018, time=2018-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266628, encodeId=e6d72666284f, content=学习了.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Dec 04 06:39:02 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517460, encodeId=1f32151e46031, content=<a href='/topic/show?id=43f265061a0' target=_blank style='color:#2F92EE;'>#泰瑞沙#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65061, encryptionId=43f265061a0, topicName=泰瑞沙)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2caa11077853, createdName=LShY0906_98743847, createdTime=Sun Dec 03 02:35:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265986, encodeId=3c9126598636, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Dec 01 17:10:52 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265954, encodeId=27ee26595498, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Fri Dec 01 12:48:02 CST 2017, time=2017-12-01, status=1, ipAttribution=)]
    2017-12-04 1209e435m98(暂无昵称)

    学习了.谢谢分享!

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1839557, encodeId=4fec183955e89, 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=31, 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=Thu Dec 21 09:35:00 CST 2017, time=2017-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059671, encodeId=b69920596e1f7, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Wed Jan 24 07:35:00 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890679, encodeId=755918906e91d, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Sat Dec 09 08:35:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805135, encodeId=83ea180513566, content=<a href='/topic/show?id=3138e790655' target=_blank style='color:#2F92EE;'>#细胞性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77906, encryptionId=3138e790655, topicName=细胞性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Sep 22 15:35:00 CST 2018, time=2018-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266628, encodeId=e6d72666284f, content=学习了.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Dec 04 06:39:02 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517460, encodeId=1f32151e46031, content=<a href='/topic/show?id=43f265061a0' target=_blank style='color:#2F92EE;'>#泰瑞沙#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65061, encryptionId=43f265061a0, topicName=泰瑞沙)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2caa11077853, createdName=LShY0906_98743847, createdTime=Sun Dec 03 02:35:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265986, encodeId=3c9126598636, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Dec 01 17:10:52 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265954, encodeId=27ee26595498, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Fri Dec 01 12:48:02 CST 2017, time=2017-12-01, status=1, ipAttribution=)]
    2017-12-03 LShY0906_98743847

    #泰瑞沙#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1839557, encodeId=4fec183955e89, 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=31, 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=Thu Dec 21 09:35:00 CST 2017, time=2017-12-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059671, encodeId=b69920596e1f7, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Wed Jan 24 07:35:00 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1890679, encodeId=755918906e91d, content=<a href='/topic/show?id=a867452008' target=_blank style='color:#2F92EE;'>#CFDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4520, encryptionId=a867452008, topicName=CFDA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1a19115, createdName=stfoxst, createdTime=Sat Dec 09 08:35:00 CST 2017, time=2017-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1805135, encodeId=83ea180513566, content=<a href='/topic/show?id=3138e790655' target=_blank style='color:#2F92EE;'>#细胞性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77906, encryptionId=3138e790655, topicName=细胞性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Sep 22 15:35:00 CST 2018, time=2018-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266628, encodeId=e6d72666284f, content=学习了.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Dec 04 06:39:02 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517460, encodeId=1f32151e46031, content=<a href='/topic/show?id=43f265061a0' target=_blank style='color:#2F92EE;'>#泰瑞沙#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65061, encryptionId=43f265061a0, topicName=泰瑞沙)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=2caa11077853, createdName=LShY0906_98743847, createdTime=Sun Dec 03 02:35:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265986, encodeId=3c9126598636, content=学习一下谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzaiabIFicf63hKvVMjL6aJlx4yX4UcXmzX9DyibCRcicq0QtCRWMaQKh8MYjE1D3EKUBopgiaGWYuqbeR/0, createdBy=0c2b1999806, createdName=三生有幸9135, createdTime=Fri Dec 01 17:10:52 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265954, encodeId=27ee26595498, content=学习了新知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201006/4db877c2887649beb09cb5effd0b38c7/916f66edd48a4e77b20ebc3e14b6e45c.jpg, createdBy=141e1980133, createdName=Y—xianghai, createdTime=Fri Dec 01 12:48:02 CST 2017, time=2017-12-01, status=1, ipAttribution=)]
    2017-12-01 三生有幸9135

    学习一下谢谢分享

    0

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    2017-12-01 Y—xianghai

    学习了新知识

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