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研发日报丨一线治疗NSCLC！罗氏Tecentriq组合方案获CHMP推荐

2019-07-31 佚名 新浪医药新闻

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默沙东Keytruda组合疗法3期临床达到主要终点；最新临床失败、加速评估被撤、用药被限制诺华最近有点背！；一线治疗NSCLC！罗氏Tecentriq组合方案获CHMP积极推荐；Lynparza获英国NICE批准 用于BRCAm卵巢癌一线维持治疗……

【2019.7.30/研发NEWS】默沙东Keytruda组合疗法3期临床达到主要终点；最新临床失败、加速评估被撤、用药被限制诺华最近有点背！；一线治疗NSCLC！罗氏Tecentriq组合方案获CHMP积极推荐；Lynparza获英国NICE批准 用于BRCAm卵巢癌一线维持治疗……

我们专注医药研发最新动态，给研发人员提供及时准确的信息参考。（点击标题，可阅读原文）

默沙东Keytruda组合疗法3期临床达到主要终点

7月29日，默沙东宣布，其抗PD-1检查点抑制剂Keytruda（pembrolizumab）与化学疗法相结合，在三阴性乳腺癌的III期KEYNOTE-522试验中达到了主要终点。基于独立数据监测委员会的中期分析，与单独化疗相比，KEYTRUDA+化疗显示，无论PD-L1状态如何，病理完全反应率在统计学意义上有着明显的改善。

最新临床失败、加速评估被撤、用药被限制诺华最近有点背！

近日，诺华宣布评估心衰药物Entresto治疗射血分数保留的心力衰竭的全球性III期临床研究PARAGON-HF没有达到主要终点。此外，欧洲药品管理局人用医药产品委员会（CHMP）最近宣布，将诺华治疗脊髓性肌萎缩症的基因疗法Zolgensma从加速评估项目中剔除。而在上周，CHMP对诺华的口服多发性硬化症药物Gilenya提出了最新的限制：不得用于孕妇或不能使用有效避孕措施的女性。如果女性在服用Gilenya时怀孕，必须停止用药，并密切监测怀孕情况。

三生制药预充式益赛普水针递交新药生产申请并获得受理

7月29日，三生制药宣布，旗下三生国健药业（上海）股份有限公司自主研发的抗体融合蛋白药物产品预充式益赛普水针剂已向国家药品监督管理局递交新药生产申请并获得受理。此次预充式益赛普水针剂是中国第一个自主研发的预充式融合蛋白注射液。其用于三个适应症的治疗：活动性强直性脊柱炎、中度及重度活动性类风湿关节炎、18岁及18岁以上成人中度及重度斑块状银屑病。

一线治疗NSCLC！罗氏Tecentriq组合方案获CHMP积极推荐

近日，罗氏宣布，欧洲药品管理局人用药品委员会建议批准其重磅免疫疗法Tecentriq联合卡铂和Abraxane（白蛋白结合紫杉醇，即nab-紫杉醇）化疗用于一线治疗无EGFR或ALK阳性突变的转移性非鳞状非小细胞肺癌成人患者。

Lynparza获英国NICE批准 用于BRCAm卵巢癌一线维持治疗

近日，英国NICE批准阿斯利康靶向抗癌药Lynparza用于英国国家卫生服务系统，作为一种一线维持疗法，用于接受一线含铂化疗后病情缓解的BRCA突变（BRCAm）晚期卵巢癌患者，具体为：携带BRCA1/2突变的晚期（FIGO分期：III期和IV期）上皮卵巢癌、输卵管癌或原发性腹膜癌患者。

新型抗代谢复方药Lonsurf获欧盟CHMP推荐批准 治疗转移性胃癌

近日，法国药企施维雅与合作伙伴大鹏制药联合宣布，欧洲药品管理局人用医药产品委员会已发布积极审查意见，推荐批准Lonsurf（trifluridine/tipiracil）用于既往已接受至少2种系统治疗方案控制晚期疾病的转移性胃癌（包括转移性胃食管交界腺癌）成人患者的治疗。

首个植物来源大麻素药物大麻二醇欧盟批准在即

近日，GW Pharma公司宣布，欧洲药品管理局人用医药产品委员会已发布积极审查意见，推荐批准Epidyolex（cannabidiol，大麻二醇，CBD）口服液体制剂用于2岁及以上患者，辅助治疗与Lennox-Gastaut综合征和Dravet综合征相关的癫痫。

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1652359, encodeId=1b85165235953, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Mon Jul 13 02:33:00 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300293, encodeId=36591300293c5, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302669, encodeId=7f6c1302669f2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1509573, encodeId=d88e15095e318, content=<a href='/topic/show?id=b2bd1e246ab' target=_blank style='color:#2F92EE;'>#Tecentriq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17246, encryptionId=b2bd1e246ab, topicName=Tecentriq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2d810099674, createdName=lfyang, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039700, encodeId=cacc1039e00b4, content=NSCLC下一步突破在于新靶点了，靶向治疗和免疫治疗基本见顶了，再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jul 31 15:33:00 CST 2019, time=2019-07-31, status=1, ipAttribution=)]
    2020-07-13 shock_melon

    #TEC#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1652359, encodeId=1b85165235953, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Mon Jul 13 02:33:00 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300293, encodeId=36591300293c5, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302669, encodeId=7f6c1302669f2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1509573, encodeId=d88e15095e318, content=<a href='/topic/show?id=b2bd1e246ab' target=_blank style='color:#2F92EE;'>#Tecentriq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17246, encryptionId=b2bd1e246ab, topicName=Tecentriq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2d810099674, createdName=lfyang, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039700, encodeId=cacc1039e00b4, content=NSCLC下一步突破在于新靶点了，靶向治疗和免疫治疗基本见顶了，再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jul 31 15:33:00 CST 2019, time=2019-07-31, status=1, ipAttribution=)]
    2019-08-02 lqvr

    #研发#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1652359, encodeId=1b85165235953, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Mon Jul 13 02:33:00 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300293, encodeId=36591300293c5, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302669, encodeId=7f6c1302669f2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1509573, encodeId=d88e15095e318, content=<a href='/topic/show?id=b2bd1e246ab' target=_blank style='color:#2F92EE;'>#Tecentriq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17246, encryptionId=b2bd1e246ab, topicName=Tecentriq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2d810099674, createdName=lfyang, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039700, encodeId=cacc1039e00b4, content=NSCLC下一步突破在于新靶点了，靶向治疗和免疫治疗基本见顶了，再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jul 31 15:33:00 CST 2019, time=2019-07-31, status=1, ipAttribution=)]
    2019-08-02 医生2394

    #CHMP#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1652359, encodeId=1b85165235953, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Mon Jul 13 02:33:00 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300293, encodeId=36591300293c5, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302669, encodeId=7f6c1302669f2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1509573, encodeId=d88e15095e318, content=<a href='/topic/show?id=b2bd1e246ab' target=_blank style='color:#2F92EE;'>#Tecentriq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17246, encryptionId=b2bd1e246ab, topicName=Tecentriq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2d810099674, createdName=lfyang, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039700, encodeId=cacc1039e00b4, content=NSCLC下一步突破在于新靶点了，靶向治疗和免疫治疗基本见顶了，再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jul 31 15:33:00 CST 2019, time=2019-07-31, status=1, ipAttribution=)]
    2019-08-02 lfyang

    #Tecentriq#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1652359, encodeId=1b85165235953, content=<a href='/topic/show?id=13d01e24509' target=_blank style='color:#2F92EE;'>#TEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17245, encryptionId=13d01e24509, topicName=TEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=852f24292001, createdName=shock_melon, createdTime=Mon Jul 13 02:33:00 CST 2020, time=2020-07-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1300293, encodeId=36591300293c5, content=<a href='/topic/show?id=ed5ee332423' target=_blank style='color:#2F92EE;'>#研发#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=73324, encryptionId=ed5ee332423, topicName=研发)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=aea0290, createdName=lqvr, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1302669, encodeId=7f6c1302669f2, content=<a href='/topic/show?id=1b6846653e' target=_blank style='color:#2F92EE;'>#CHMP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4665, encryptionId=1b6846653e, topicName=CHMP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b505306, createdName=医生2394, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1509573, encodeId=d88e15095e318, content=<a href='/topic/show?id=b2bd1e246ab' target=_blank style='color:#2F92EE;'>#Tecentriq#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17246, encryptionId=b2bd1e246ab, topicName=Tecentriq)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b2d810099674, createdName=lfyang, createdTime=Fri Aug 02 03:33:00 CST 2019, time=2019-08-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039700, encodeId=cacc1039e00b4, content=NSCLC下一步突破在于新靶点了，靶向治疗和免疫治疗基本见顶了，再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jul 31 15:33:00 CST 2019, time=2019-07-31, status=1, ipAttribution=)]
    2019-07-31 肿肿

    NSCLC下一步突破在于新靶点了，靶向治疗和免疫治疗基本见顶了，再有新的就需要新机制了

    0