恒瑞医药「甲磺酸阿帕替尼片」新适应症获批:治疗肝细胞癌

2021-01-10 医药魔方 医药魔方

近日,恒瑞医药甲磺酸阿帕替尼片新适应症(化学药品2.4类)上市申请(受理号:CXHS2000004)获NMPA批准,用于治疗既往接受过至少一线系统性治疗后失败或不可耐受的晚期肝细胞癌患者。这是阿帕替尼

近日,恒瑞医药甲磺酸阿帕替尼片新适应症(化学药品2.4类)上市申请(受理号:CXHS2000004)获NMPA批准,用于治疗既往接受过至少一线系统性治疗后失败或不可耐受的晚期肝细胞癌患者。这是阿帕替尼获批的第2个适应症。

一项针对既往接受过至少一线系统性治疗(索拉非尼和奥沙利铂)失败或不可耐受晚期肝细胞癌患者的 III 期临床(NCT02329860)研究结果显示,与安慰剂组相比,阿帕替尼组总生存期显着延长(8.7 vs 6.8个月),患者死亡风险降低(HR:0.785,p=0.0476)。

阿帕替尼组较安慰剂组显着延长无进展生存期(4.5 vs 1.9个月,HR:0.471,0.0001)也显着提高客观缓解率(10.7% vs 1.5%)。 安全性方面,最常见≥3级以上不良反应发生率分别为高血压(阿帕替尼组71例(27.6%) vs安慰剂组3例(2.3%)),手足综合征(46 (17.9%) vs 0),血小板计数减少(34(13.2%) vs 1 (0.8%)),中性粒细胞计数减少(27 (10.5%)vs 0)。 甲磺酸阿帕替尼是恒瑞自主研发的1类小分子靶向血管内皮细胞生长因子受体2(VEGFR-2)酪氨酸激酶抑制剂,于2014 年首次获NMPA批准上市用于治疗既往至少接受过 2 种系统化疗后进展或复发的晚期胃腺癌或胃-食管结合部腺癌患者。 此外,阿帕替尼单药或与卡瑞利珠单抗、氟唑帕利、SHR-1210或依托泊苷软胶囊联合治疗乳腺癌卵巢癌、非小细胞肺癌多种实体肿瘤适应症已处于临床开发阶段。

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    2021-01-11 cathymary
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    2021-01-10 科研科研科研

    #肿瘤##阿帕替尼#1类小分子靶向血管内皮细胞生长因子首体2洛氨酸激酶抑制剂

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1863530, encodeId=2c2d18635303e, content=<a href='/topic/show?id=c0b68135561' target=_blank style='color:#2F92EE;'>#肝细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=81355, encryptionId=c0b68135561, topicName=肝细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=d59291, createdName=xjy02, createdTime=Wed Dec 22 01:23:11 CST 2021, time=2021-12-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1979058, encodeId=660219e9058a8, content=<a href='/topic/show?id=3b90e79787f' target=_blank style='color:#2F92EE;'>#细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77978, encryptionId=3b90e79787f, topicName=细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e457184, createdName=qingting, createdTime=Mon May 10 08:23:11 CST 2021, time=2021-05-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336830, encodeId=104a13368302d, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Mon Jan 11 15:23:11 CST 2021, time=2021-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410096, encodeId=868914100960d, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Mon Jan 11 15:23:11 CST 2021, time=2021-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416222, encodeId=427a141622230, content=<a href='/topic/show?id=a24f58e0879' target=_blank style='color:#2F92EE;'>#新适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58708, encryptionId=a24f58e0879, topicName=新适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=395f25, createdName=爆笑小医, createdTime=Mon Jan 11 15:23:11 CST 2021, time=2021-01-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915390, encodeId=3f9291539060, content=<a href='/topic/show?id=aa0582e6946' target=_blank style='color:#2F92EE;'>#肿瘤#</a><a href='/topic/show?id=196b9e808ed' target=_blank style='color:#2F92EE;'>#阿帕替尼#</a>1类小分子靶向血管内皮细胞生长因子首体2洛氨酸激酶抑制剂, beContent=null, objectType=article, channel=null, level=null, likeNumber=144, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82769, encryptionId=aa0582e6946, topicName=肿瘤), TopicDto(id=97808, encryptionId=196b9e808ed, topicName=阿帕替尼)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210110/e6124a4b19bc40ce8afaae096d21126b/dd778ac260c9416eb87e7d08139507f5.jpg, createdBy=4d2f5079605, createdName=科研科研科研, createdTime=Sun Jan 10 22:06:37 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915389, encodeId=913891538919, content=阿帕替尼治疗晚期肝细胞癌患者,, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210110/e6124a4b19bc40ce8afaae096d21126b/dd778ac260c9416eb87e7d08139507f5.jpg, createdBy=4d2f5079605, createdName=科研科研科研, createdTime=Sun Jan 10 22:03:59 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915332, encodeId=193b91533252, content=阿帕替尼治疗肝癌, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Sun Jan 10 19:06:11 CST 2021, time=2021-01-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=915165, encodeId=916f91516514, content=非常好,学习了!, beContent=null, objectType=article, channel=null, level=null, likeNumber=81, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3be85451515, createdName=ms3000001264084725, createdTime=Sun Jan 10 10:54:16 CST 2021, time=2021-01-10, status=1, ipAttribution=)]
    2021-01-10 科研科研科研

    阿帕替尼治疗晚期肝细胞癌患者,

    0

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    2021-01-10 oo902

    阿帕替尼治疗肝癌

    0

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    2021-01-10 ms3000001264084725

    非常好,学习了!

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