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罗氏安维汀(贝伐珠单抗注射液)胶质母细胞瘤适应症获批,为中国患者带来全新治疗选择

2020-09-22 MedSci MedSci

2020年9月21日,罗氏宣布中国国家药品监督管理局(NMPA)批准安维汀®(英文商品名:Avastin;通用名:贝伐珠单抗注射液)用于成人复发性胶质母细胞瘤(GBM)患者的治疗。

2020年9月21日,罗氏宣布中国国家药品监督管理局(NMPA)批准安维汀®(英文商品名:Avastin;通用名:贝伐珠单抗注射液)用于成人复发性胶质母细胞瘤(GBM)患者的治疗。目前,安维汀®已先后在国内获批联合化疗用于转移性结直肠癌的治疗,以及不可切除的晚期、转移性或复发性非鳞状细胞非小细胞肺癌患者的一线治疗。此次新适应症获批将为中国胶质母细胞瘤患者带来新的治疗选择。
 
胶质母细胞瘤是成人最常见且恶性程度最高的原发性颅内肿瘤。2017年中国肿瘤登记年报数据显示,我国脑瘤的发病率为7.61/10万,其中胶质母细胞瘤占恶性脑肿瘤的46.1%,年发病率约为2.8/10万,具有发病率高、复发率高、死亡率高和治愈率低的特点,被认为是神经外科领域治疗难度最高的肿瘤之一。
 
中国抗癌协会脑胶质瘤专委会主任委员、中国医师协会脑胶质瘤专业委员会首任主任委员、北京市神经外科研究所副所长、首都医科大学附属北京天坛医院神经外科中心副主任江涛教授表示:“目前,我国胶质母细胞瘤的治疗以手术为主,规范化的放疗、化疗、定期复查为辅。但即便经过术后标准的放、化疗,患者预后仍然不佳,几乎所有患者均会在一线治疗后出现复发,五年生存率极低,神经认知功能和生活质量均呈进行性下降。以恶性胶质瘤为代表的中枢神经系统恶性肿瘤已造成了巨大的家庭及社会负担。”
 
脑胶质瘤治疗过程中常见脑水肿和颅内压增高等症状,常用皮质类固醇激素进行相应对症治疗。但大剂量使用皮质类固醇激素可能导致高血压、骨质疏松、胃溃疡等副作用,造成患者免疫力进一步下降,在很大程度上影响着患者的生存质量。
 
安维汀®(贝伐珠单抗注射液)获批用于治疗成人复发性胶质母细胞瘤主要基于一项多中心、开放标签、随机对照的关键性III期临床试验EORTC 26101。该研究结果证实,与单独化疗相比,基于安维汀®(贝伐珠单抗注射液)的治疗延长了无疾病进展或死亡的时间(中位PFS: 4.2个月 vs. 1.5个月, HR=0.52, 95%CI: 0.41-0.64),疾病进展风险可降低51%。在无进展生存期内,疾病缓解的患者与非缓解者相比,显示出更稳定的全球健康状况评分和认知功能。
 
“胶质母细胞瘤有着极其丰富的异常新生血管。通过靶向血管生成过程中的关键调控分子VEGF,贝伐珠单抗可以减少肿瘤血管生成,从而抑制肿瘤生长和血管源性脑水肿。”中华医学会神经外科学分会候任主任委员、复旦大学附属华山医院院长毛颖教授表示,“贝伐珠单抗也可以使形态紊乱、管壁通透性高的肿瘤血管功能和结构均趋向正常化,将化疗药物更有效地传递进肿瘤组织,增强肿瘤细胞对于化疗药物的敏感性。具体适用的胶质瘤患者人群还需要更深入地覆盖机制开展研究,以及临床经验的积累。”
 
中国抗癌协会神经肿瘤专业委员会主任委员、中山大学肿瘤防治中心陈忠平教授表示:“相较于传统疗法,贝伐珠单抗可以延长复发胶质瘤患者无进展生存期,降低患者对皮质类固醇的依赖,有效提升患者的生活质量。此次贝伐珠单抗的获批弥补了我国复发性胶质母细胞瘤治疗领域的空白,对于提高我国复发性胶质母细胞瘤诊疗水平具有重要意义,将为广大缺乏有效治疗方案的患者带来福音。”
 
贝伐珠单抗是继替莫唑胺后胶质母细胞瘤治疗中最重要的治疗药物之一。作为复发性胶质母细胞瘤患者的建议疗法,目前被列入包括NCCN、ESMO、国家卫健委《脑胶质瘤诊疗规范》、中国中枢神经系统胶质瘤靶向免疫和电场治疗专家共识等在内的国内外权威指南及共识,也已在美国、瑞士、日本、韩国等80多个国家和地区获批用于胶质母细胞瘤的治疗。
 
罗氏制药中国总裁周虹表示:“今年是安维汀®进入中国的十周年。作为全球首款抗肿瘤血管生成治疗药物,安维汀®已累计惠及超过三十万名中国结直肠癌和非小细胞肺癌患者。此次胶质母细胞瘤适应症的获批再次体现了中国政府致力于改善人民健康、实践健康中国战略的决心。未来,我们将一如既往地秉持‘先患者之需而行’的理念,将更多罗氏创新药物带入中国,更好服务中国患者。”

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  4. 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  5. 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  6. 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  7. 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createdBy=bf5e7252474, createdName=spoonycyy, createdTime=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477061, encodeId=694714e70616c, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=)]
    2020-09-26 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

  8. 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  9. 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createdBy=bf5e7252474, createdName=spoonycyy, createdTime=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477061, encodeId=694714e70616c, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=)]
  10. [GetPortalCommentsPageByObjectIdResponse(id=1701453, encodeId=a49a1e01453ff, content=<a href='/topic/show?id=c72ee9614da' target=_blank style='color:#2F92EE;'>#罗氏安维汀#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79614, encryptionId=c72ee9614da, topicName=罗氏安维汀)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=92cd30370684, createdName=手留余香, createdTime=Sun Sep 27 05:11:55 CST 2020, time=2020-09-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2052937, encodeId=fbef205293e84, content=<a href='/topic/show?id=ae848406335' target=_blank style='color:#2F92EE;'>#胶质母细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84063, encryptionId=ae848406335, topicName=胶质母细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a691420, createdName=30397604, createdTime=Fri Oct 02 05:11:55 CST 2020, time=2020-10-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1772367, encodeId=4d1b1e72367f2, content=<a href='/topic/show?id=c38963544cc' target=_blank style='color:#2F92EE;'>#母细胞瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63544, encryptionId=c38963544cc, topicName=母细胞瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b07438375157, createdName=huperzia, createdTime=Fri Nov 20 14:11:55 CST 2020, time=2020-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2028917, encodeId=83ed202891e43, content=<a href='/topic/show?id=76463619101' target=_blank style='color:#2F92EE;'>#单抗注射液#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36191, encryptionId=76463619101, topicName=单抗注射液)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erCiat0j36p5MejdM9yCLtcVcY8WS5VIKuCMqXFNs56U6iacZib5CJvh6mVxGERicM6ZAkl91jMgpcDrw/132, createdBy=37622500012, createdName=ms2999106592497887, createdTime=Tue Jul 27 23:11:55 CST 2021, time=2021-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1954825, encodeId=027f195482542, content=<a href='/topic/show?id=e4f39220658' target=_blank style='color:#2F92EE;'>#贝伐珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92206, encryptionId=e4f39220658, topicName=贝伐珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Mon Nov 23 10:11:55 CST 2020, time=2020-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1772735, encodeId=6ed51e7273537, content=<a href='/topic/show?id=871064e139b' target=_blank style='color:#2F92EE;'>#治疗选择#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=64713, encryptionId=871064e139b, topicName=治疗选择)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=015a38388258, createdName=liye789132264, createdTime=Sat Dec 05 04:11:55 CST 2020, time=2020-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=888607, encodeId=c5b388860e81, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=116, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Sat Sep 26 22:52:51 CST 2020, time=2020-09-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336820, encodeId=f4711336820c4, 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=44, 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=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1476098, encodeId=6b9814e60982c, content=<a href='/topic/show?id=2bcee797732' target=_blank style='color:#2F92EE;'>#细胞瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77977, encryptionId=2bcee797732, topicName=细胞瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=bf5e7252474, createdName=spoonycyy, createdTime=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1477061, encodeId=694714e70616c, content=<a href='/topic/show?id=c32e9220221' target=_blank style='color:#2F92EE;'>#贝伐#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=92202, encryptionId=c32e9220221, topicName=贝伐)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ef557344179, createdName=sunrural_42825359, createdTime=Thu Sep 24 11:11:55 CST 2020, time=2020-09-24, status=1, ipAttribution=)]
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