武田宣布美国FDA将优先审理Mobocertinib (TAK-788)治疗EGFR外显子20插入+转移性非小细胞肺癌的新药报批

2021-04-29 国际文传国际文传

武田宣布美国FDA将优先审理mobocertinib (TAK-788)的新药报批(NDA)，该药用于对表皮生长因子受体(EGFR)外显子20插入突变阳性（插入+）转移性非小细胞肺癌成人患者的治疗。

−处方药使用者费用法案(PDUFA)目标行动日期定于2021年10月26日

武田药品工业株式会(Takeda Pharmaceutical Company Limited, TSE:4502/NYSE:TAK)（“武田”）今天宣布，美国食品药品管理局(FDA)将优先审理该公司mobocertinib (TAK-788)的新药报批(NDA)，该药用于对表皮生长因子受体(EGFR)外显子20插入突变阳性（插入+）转移性非小细胞肺癌(mNSCLC)成人患者（经FDA核准的检测检出）的治疗。mobocertinib是首个专门设计用于选择性靶向作用于EGFR外显子20插入突变的口服药物。

武田肿瘤治疗领域部门主管Christopher Arendt表示：“EGFR外显子20插入+ mNSCLC患者面临巨大挑战，因为现有治疗选择收益有限，导致生存转归不良。我们很高兴距离mobocertinib成为先前接受过含铂化疗的伴EGFR外显子20插入的NSCLC患者的有效口服药物更近了一步，并期待与美国及全球各地的监管部门继续对话。”

mobocertinib的此次NDA主要依据是1/2期试验的结果，试验内容为评估口服mobocertinib对mNSCLC患者的安全性和有效性。此次报批进入了FDA的加速审批计划。审理在Orbis项目下进行，Orbis项目是FDA肿瘤卓越中心(OCE)的一项倡议，为国际合作伙伴间同步报批和审理肿瘤科产品提供了一个框架。

武田已针对美国患者设立扩点获药项目(EAP) (NCT04535557)，美国患者在NDA审理期间或有资格获得mobocertinib。有关武田EAP的进一步信息，请点击此处。

关于Mobocertinib (TAK-788)

Mobocertinib是一种在研、同类首创、酪氨酸激酶抑制剂(TKI)口服治疗药物，专门设计用于选择性靶向作用于表皮生长因子受体(EGFR)外显子20插入突变。2019年，mobocertinib获得美国FDA孤儿药认证，用于治疗伴HER2突变或EGFR突变（包括外显子20插入突变）的肺癌。2020年4月，mobocertinib获得FDA突破性治疗药物认证，用于含铂化疗期间或之后疾病进展的伴EGFR外显子20插入+转移性非小细胞肺癌(mNSCLC)患者。2020年10月，mobocertinib获得中国药品审评中心(CDE)突破性治疗药物认证，用于先前已接受过至少一种全身化疗的伴EGFR外显子20突变的局部晚期或转移性NSCLC患者。

关于该项1/2期试验

该项1/2期试验旨在评估口服mobocertinib在非小细胞肺癌(NSCLC)患者中的安全性、药代动力学和抗肿瘤活性。该试验包括1期剂量递增试验（评估mobocertinib单药治疗和与化疗联合）、若干扩群队列以及伴表皮生长因子受体(EGFR)外显子20插入+转移性NSCLC (mNSCLC)患者中的一个延伸队列。

先前接受含铂治疗的群体有效性分析调查该项1/2期试验中接受含铂治疗并接受mobocertinib 160毫克每日一次治疗的114例EGFR 外显子20插入+ mNSCLC患者。

关于EGFR外显子20插入+ mNSCLC

非小细胞肺癌(NSCLC)是最常见的肺癌类型，据世界卫生组织数据，其占全球每年约180万例新诊断肺癌病例的约85%。表皮生长因子受体(EGFR)外显子20插入+转移性NSCLC (mNSCLC)占NSCLC患者的约1-2%，亚裔人群中较西方人群中更常见。该病预后比其他EGFR突变型差，因为目前FDA尚未核准靶向作用于EGFR外显子20插入的治疗药物，而现有EGFR TKI和化疗对这些患者的益处有限。

武田承诺继续EGFR外显子20插入+ mNSCLC领域的研发，以期为全世界每年约3万例（包括仅美国就有3,000例）获诊该病的患者提供一款靶向治疗选择。

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#插入话题

插入图片

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2022-04-01 lingaifan

#非小细胞#

25 0
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2021-05-01 1249842em09(暂无昵称)

#转移性#

22 0
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2021-05-01 anan

#转移性非小细胞肺癌#

28 0
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2021-05-01 12498f17m69暂无昵称

#武田#

31 0
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2021-05-01 liuyiping

#GFR#

0 0
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2021-05-01 10518098zz

#美国FDA#

25 0
[GetPortalCommentsPageByObjectIdResponse(id=2059972, encodeId=0ff820599e2f8, 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=Fri Apr 01 23:36:51 CST 2022, time=2022-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386750, encodeId=c9c91386e50e0, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Sat May 01 01:36:51 CST 2021, time=2021-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472018, encodeId=28ac14e201886, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Sat May 01 01:36:51 CST 2021, time=2021-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1517272, encodeId=a224151e27216, content=<a href='/topic/show?id=a0176333892' target=_blank style='color:#2F92EE;'>#武田#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, 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 May 01 01:36:51 CST 2021, time=2021-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534543, encodeId=0502153454378, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Sat May 01 01:36:51 CST 2021, time=2021-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1551513, encodeId=a18e1551513b2, content=<a href='/topic/show?id=5d84e9716c0' target=_blank style='color:#2F92EE;'>#美国FDA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79716, encryptionId=5d84e9716c0, topicName=美国FDA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a46914191431, createdName=10518098zz, createdTime=Sat May 01 01:36:51 CST 2021, time=2021-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1619079, encodeId=5b6516190e98d, content=<a href='/topic/show?id=492a42862bd' target=_blank style='color:#2F92EE;'>#外显子#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=42862, encryptionId=492a42862bd, topicName=外显子)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=docwu2019, createdTime=Sat May 01 01:36:51 CST 2021, time=2021-05-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=961486, encodeId=e185961486c1, content=关于该项1/2期试验, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=[AttachmentDto(url=https://img.medsci.cn/comment/20210429/e472eadce57040c49ed2eaf9681e642f.jpg, type=image, width=667, height=385)], authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210706/5924e86cc73c43efb5bad9dd92ac0d7b/63609a5527c447f48b59b39dd248a66f.jpg, createdBy=cf0a5102349, createdName=站在塔尖, createdTime=Thu Apr 29 12:21:19 CST 2021, time=2021-04-29, status=1, ipAttribution=)]
2021-05-01 docwu2019

#外显子#

37 0
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2021-04-29 站在塔尖

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武田宣布美国FDA将优先审理Mobocertinib (TAK-788)治疗EGFR外显子20插入+转移性非小细胞肺癌的新药报批

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