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全球用于治疗BRAFV600突变阳性的无法手术切除或转移性黑色素瘤的靶向新药佐博伏® 中国上市 CFDA审评概述

2017-12-01 新浪医药 新浪医药

7月29日,上海罗氏制药有限公司宣布,公司研发的全球首个用于治疗BRAFV600突变阳性的无法手术切除或转移性黑色素瘤的靶向新药佐博伏®(维莫非尼,Vemurafenib)在中国正式上市。恶性黑色素瘤是一种发病率极低致死率极高的恶性肿瘤,在欧美日等国均被定义为罕见病;亚洲发病率显着低于西方,现有流行病学数据显示中国发病率仅为0.48/10万(美国21.6/10万)。转移性黑色素瘤是致死率最高的癌症


7月29日,上海罗氏制药有限公司宣布,公司研发的全球首个用于治疗BRAFV600突变阳性的无法手术切除或转移性黑色素瘤的靶向新药佐博伏®(维莫非尼,Vemurafenib)在中国正式上市。

恶性黑色素瘤是一种发病率极低致死率极高的恶性肿瘤,在欧美日等国均被定义为罕见病;亚洲发病率显着低于西方,现有流行病学数据显示中国发病率仅为0.48/10万(美国21.6/10万)。转移性黑色素瘤是致死率最高的癌症之一,IV期患者5年生存率仅为4.6%。BRAF突变与黑色素瘤患者较差的预后相关(中国患者突变率约24-28%),据估算中国每年BRAF V600 突变的III /IV期黑色素瘤患者不足***。

本次在中国批准适应症为“维莫非尼适用于治疗经CFDA批准的检测方法确定的BRAF V600 突变阳性的不可切除或转移性黑色素瘤”,用法用量为“960mg,口服,每日两次”。

支持该品种在中国批准上市的主要临床试验数据为全球关键III期研究NO25026(一线治疗)、II期研究NP22657(一线治疗失败的患者)及一项中国患者I期研究(YO28390)。

研究NO25026是一项随机、对照、开放设计的全球关键III期研究,既往未接受过针对晚期疾病化疗的BRAF V600突变阳性无法切除/转移性黑色素瘤( IIIC/IV期,AJCC)患者随机接受维莫非尼或达卡巴嗪治疗。研究共入选675名受试者,其中包括维莫非尼组337名,达卡巴嗪组338名。研究结果显示确认ORR 57% vs 9%,中位OS 13.6 vs 9.7个月,HR=0.70 (95% CI: 0.57, 0.87),中位PFS 6.9 vs. 1.6 个月,HR =0.38 (95% CI: 0.32, 0.46),维莫非尼组具有统计学显着的临床获益。

研究NP22657是一项在至少接受过一次既往治疗的转移性黑色素瘤患者中进行的II期、单组、国际多中心研究。共入选132名患者,其中49%的患者既往治疗失败的次数 ≥ 2,中位随访时间为6.87个月(范围0.6至11.3个月之间)。主要终点——独立审查委员会评估的经确认的最佳总体缓解率(CR + PR)为52%(95%置信区间:43%,61%),中位缓解持续时间为6.5个月(95%置信区间:5.6,未达到)。在30%的患者中,观察到基于RECIST 1.1判定的疾病稳定。中位总生存期尚未达到(95%置信区间:9.5个月,未达到),6个月生存率为77%(95%置信区间:70%,85%)。中位PFS为6.1个月(95%置信区间:5.5,6.9),6个月PFS率为52%(95%置信区间:43%,61%)。

研究YO28390是一项在中国患者中开展的I期、单组临床研究,包含一个PK队列(N=20)和一个扩展队列(N=26)。由研究者评估,经确认的最佳总体缓解率为52%(95%置信区间:37%,67%)。中位缓解持续时间为9.1个月(95%置信区间:7.4,未达到)。在46%的患者中,观察到基于RECIST 1.1判定的疾病稳定。中位PFS为8.3个月(95%置信区间:5.7,10.9),中位总生存期为13.5个月(95%置信区间:12.2个月,未达到)。中国患者的药代动力学特征基本与在高加索人人群中观察到的特征一致,中国患者接受治疗后观察到的疗效与在高加索人人群中观察到的疗效基本一致。中国患者接受维莫非尼治疗的客观缓解率与达卡巴嗪中国历史数据相比有显着提高(52% vs 3.7%)。

安全性方面,维莫非尼治疗最常见不良事件为皮肤和皮下组织病症,包括脱发、皮疹和光敏反应。III期研究NO25026中接受维莫非尼治疗的患者中发生率≥10%并且发生率大于对照组达卡巴嗪两倍的其他不良事件包括皮肤鳞状细胞癌(cuSCC)、皮肤乳头状瘤、关节痛、头痛、味觉障碍、发热、外周性水肿、肢体疼痛、肌痛、食欲下降、腹泻、角化过度、脂溢性角化病和皮肤干燥。中国患者接受维莫非尼治疗的总体耐受性良好,未发现新的安全性信号。

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    2018-05-26 sunylz
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channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75519, encryptionId=0b3fe551971, topicName=突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKjqGDO7icVKUiaT7urgwXvnvzWtp0fMFU46Xfib8oavFKygiaWtibXReS6ZUh3PImsNicGAwTO5HXxoicnA/132, createdBy=ee262500130, createdName=ms7474195563676018, createdTime=Tue Jun 12 06:22:00 CST 2018, time=2018-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266625, encodeId=07f626662569, content=学习了.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Dec 04 06:38:38 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429414, encodeId=721c14294142a, content=<a href='/topic/show?id=bb015438221' target=_blank style='color:#2F92EE;'>#手术切除#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54382, encryptionId=bb015438221, topicName=手术切除)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfdd4195665, createdName=s_pl2009, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564865, encodeId=231b15648658c, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558856, encodeId=cb001558856b7, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=)]
  4. [GetPortalCommentsPageByObjectIdResponse(id=1680472, encodeId=7ee916804e25f, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Sat May 26 11:22:00 CST 2018, time=2018-05-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1932085, encodeId=a3401932085c9, content=<a href='/topic/show?id=f71299916ac' target=_blank style='color:#2F92EE;'>#靶向新药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99916, encryptionId=f71299916ac, topicName=靶向新药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e2dd327, 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channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75519, encryptionId=0b3fe551971, topicName=突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKjqGDO7icVKUiaT7urgwXvnvzWtp0fMFU46Xfib8oavFKygiaWtibXReS6ZUh3PImsNicGAwTO5HXxoicnA/132, createdBy=ee262500130, createdName=ms7474195563676018, createdTime=Tue Jun 12 06:22:00 CST 2018, time=2018-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266625, encodeId=07f626662569, content=学习了.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Dec 04 06:38:38 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429414, encodeId=721c14294142a, content=<a href='/topic/show?id=bb015438221' target=_blank style='color:#2F92EE;'>#手术切除#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54382, encryptionId=bb015438221, topicName=手术切除)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfdd4195665, createdName=s_pl2009, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564865, encodeId=231b15648658c, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558856, encodeId=cb001558856b7, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=)]
    2018-08-09 stfoxst
  5. 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2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558856, encodeId=cb001558856b7, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=)]
  6. 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channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=75519, encryptionId=0b3fe551971, topicName=突变阳性)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTKjqGDO7icVKUiaT7urgwXvnvzWtp0fMFU46Xfib8oavFKygiaWtibXReS6ZUh3PImsNicGAwTO5HXxoicnA/132, createdBy=ee262500130, createdName=ms7474195563676018, createdTime=Tue Jun 12 06:22:00 CST 2018, time=2018-06-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266625, encodeId=07f626662569, content=学习了.谢谢分享!, beContent=null, objectType=article, channel=null, level=null, likeNumber=100, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Dec 04 06:38:38 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1429414, encodeId=721c14294142a, content=<a href='/topic/show?id=bb015438221' target=_blank style='color:#2F92EE;'>#手术切除#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54382, encryptionId=bb015438221, topicName=手术切除)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfdd4195665, createdName=s_pl2009, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564865, encodeId=231b15648658c, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 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  7. 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content=<a href='/topic/show?id=bb015438221' target=_blank style='color:#2F92EE;'>#手术切除#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54382, encryptionId=bb015438221, topicName=手术切除)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfdd4195665, createdName=s_pl2009, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564865, encodeId=231b15648658c, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558856, encodeId=cb001558856b7, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=)]
    2017-12-04 1209e435m98(暂无昵称)

    学习了.谢谢分享!

    0

  8. 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  9. 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content=<a href='/topic/show?id=bb015438221' target=_blank style='color:#2F92EE;'>#手术切除#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54382, encryptionId=bb015438221, topicName=手术切除)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfdd4195665, createdName=s_pl2009, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1564865, encodeId=231b15648658c, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1558856, encodeId=cb001558856b7, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=64, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Sun Dec 03 04:22:00 CST 2017, time=2017-12-03, status=1, ipAttribution=)]
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