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欧洲药品管理局验证了默克PD-L1单抗Bavencio在晚期肾细胞癌中的疗效

2019-03-08 不详 MedSci原创

欧洲药品管理局(EMA)已经验证了Merck的PD-L1单抗Bavencio(avelumab)治疗晚期肾细胞癌(RCC)患者的疗效。该次验证是基于关键的III期JAVELIN肾脏101试验的结果。

欧洲药品管理局(EMA)已经验证了Merck的PD-L1单抗Bavencio(avelumab)治疗晚期肾细胞癌(RCC)患者的疗效。该次验证是基于关键的III期JAVELIN肾脏101试验的结果。

JAVELIN涉及至少30个临床项目和超过9000名患者,评估超过15种不同的肿瘤类型。除RCC外,这些肿瘤类型还包括乳腺癌/食管癌、头颈癌,Merkel细胞癌、非小细胞肺癌和尿路上皮癌。

试验结果于2019年2月16日发表在新英格兰医学杂志上。

美国食品和药物管理局(FDA)还对该药物组合治疗晚期RCC的补充生物制剂许可申请进行了优先审查。

RCC是最常见的肾癌形式,占成人所有癌症的约2%至3%。尽管临床有可用的治疗方法,晚期RCC患者的治疗效果依然不佳。大约20%至30%的患者初次即被诊断为转移期,转移性RCC患者的5年生存率仅约为12%。

原始出处:


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createdTime=Sun Mar 10 11:49:00 CST 2019, time=2019-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1441748, encodeId=c68a1441e482c, content=<a href='/topic/show?id=09a6598e57a' target=_blank style='color:#2F92EE;'>#晚期肾细胞癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=103, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59875, encryptionId=09a6598e57a, topicName=晚期肾细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87304889998, createdName=12498c24m70暂无昵称, createdTime=Sun Mar 10 11:49:00 CST 2019, time=2019-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1538954, encodeId=12dc1538954fc, 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=87, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13924, encryptionId=349913924d1, topicName=PD-L1单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Sun Mar 10 11:49:00 CST 2019, time=2019-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032091, encodeId=46c91032091ac, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Fri Mar 08 23:49:00 CST 2019, time=2019-03-08, status=1, ipAttribution=)]
    2019-03-10 smartjoy
  5. 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encryptionId=349913924d1, topicName=PD-L1单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Sun Mar 10 11:49:00 CST 2019, time=2019-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032091, encodeId=46c91032091ac, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Fri Mar 08 23:49:00 CST 2019, time=2019-03-08, status=1, ipAttribution=)]
  6. 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  7. 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  8. 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  9. 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  10. 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encryptionId=349913924d1, topicName=PD-L1单抗)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=55683, createdName=仁医06, createdTime=Sun Mar 10 11:49:00 CST 2019, time=2019-03-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032091, encodeId=46c91032091ac, content=谢谢梅斯提供这么好的信息,学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Fri Mar 08 23:49:00 CST 2019, time=2019-03-08, status=1, ipAttribution=)]
    2019-03-08 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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充满活力的科技公司默克(Merck)今天宣布,澳大利亚专利局(Australian Patent Office)已经批准了该公司的配对规律成簇的间隔短回文重复(CRISPR)切口酶使用专利申请。配对切口酶是提高安全性的有效措施,通过高度灵活且有效的脱靶效应降低方法推动特异性。这可提高 CRISPR 固定患病基因同时不影响健康基因的能力。默克执行董事会成员兼生命科学首席执行官吴博达(Udit Bat

默克利润下滑但新药仍保持销售增长

默克公司报告第二季度净收入下降42%至2.47亿欧元(2.83亿美元),但新药Bavencio和Mavenclad帮助该公司保持了有机销售增长。收入为43亿美元,与去年同期相比略微上升0.5%。有机增长5.2%。Merkel细胞癌药物Bavencio的销售额从500万美元上升到2000万美元,MS治疗Mavenclad的收入为2300万美元。与此同时,Rebif,Erbitux和Gonal-f的收

默克将消费者医疗保健部门出售给宝洁

德国默克将其消费者健康部门以34亿欧元出售给宝洁。默克去年表示,正在考虑其消费者健康部门的未来,出售将帮助其实施以科学和技术为核心的战略。执行委员会主席兼默克首席执行官Stefan Oschmann表示,此举"清楚地证明了我们继续致力于积极塑造我们作为领先科技公司的投资组合的承诺。""消费者健康是一项强大的业务,应该为其未来发展提供尽可能好的机会。 在宝洁公司,我们找到了一个强大的,高度认可的玩家

默克公司人乳头瘤病毒疫苗Gardasil 9英国供应告急

人乳头瘤状病毒(HPV)已被证明不仅会诱发宫颈癌,而且会诱导肛门癌、宫颈原位癌、阴道癌、口咽癌等多种癌症的产生。HPV疫苗是人类首次尝试通过疫苗的方式消灭肿瘤,具有划时代的意义。

默克与腾讯宣布就中国智能数字医疗服务展开合作

今日,全球领先科技公司默克与中国领先的互联网企业腾讯签署了战略合作协议。此次合作将充分结合默克在科技领域的专业优势以及腾讯在互联网和人工智能领域的前沿技术,聚焦于在中国通过数字化平台提高公众对疾病的认识,提供更具可及性的医疗服务。 默克中国-腾讯战略合作签约仪式合影,从左至右(默克中国医药健康副总裁、业务运营部负责人唐英女士,默克中国生物制药业务董事总经理罗杰仁先生,默克医药健康执行副总裁、国际

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