乳腺癌新药Ibrance III期临床一线治疗ER+/HER2-乳腺癌获得成功

2016-04-21 佚名生物谷

美国制药巨头辉瑞（Pfizer）近日公布了突破性乳腺癌药物Ibrance（palbociclib）一项III期PALOMA-2临床研究的积极顶线数据。该研究在既往未接受系统疗法治疗晚期病情的雌激素受体阳性（ER+）、人类表皮生长因子受体2阴性（HER2-）、晚期或转移性乳腺癌绝经后女性患者中开展，数据显示，与来曲唑（letrozole）+安慰剂相比，Ibrance+来曲唑组合疗法显著延长了无进展生

美国制药巨头辉瑞（Pfizer）近日公布了突破性乳腺癌药物Ibrance（palbociclib）一项III期PALOMA-2临床研究的积极顶线数据。该研究在既往未接受系统疗法治疗晚期病情的雌激素受体阳性（ER+）、人类表皮生长因子受体2阴性（HER2-）、晚期或转移性乳腺癌绝经后女性患者中开展，数据显示，与来曲唑（letrozole）+安慰剂相比，Ibrance+来曲唑组合疗法显著延长了无进展生存期（PFS），达到了研究的主要终点。安全性方面，PALOMA-2研究中Ibrance+来曲唑联合治疗组中所观察到的不良事件与Ibrance在横跨不同患者群体及多线治疗中的已知安全性一致。Ibrance用药相关的警告及注意事项包括中性粒细胞减少症、肺栓塞、胚胎毒性。

该研究为Ibrance+来曲唑组合疗法一线治疗晚期乳腺癌提供了确凿的疗效证据，辉瑞此前在II期PALOMA-1研究中对该组合进行了首次研究。这些数据将支持Ibrance进一步的全球监管申请，而在美国市场，这些数据将用于支持Ibrance由加速批准转为完全批准。PALOMA-2研究的详细疗效和安全性数据将提交至2016年美国临床肿瘤学会（ASCO 2016）年度会议。

值得一提的是，PALOMA-2研究也标志着证实Ibrance联合激素疗法治疗ER+/HER2-晚期乳腺癌具有积极疗效的第三个随机研究。在该领域，Ibrance仍然是唯一一种已获得III期临床数据的CDK4/6抑制剂。

Ibrance：将主导HER2-乳腺癌市场，2023年销售额达到18.5亿美元

Ibrance是全球上市的首个CDK4/6抑制剂，于2015年2月获FDA加速批准，联合诺华肿瘤学药物Femara（letrozole，来曲唑）用于既往未接受过系统治疗以控制晚期病情的绝经后女性HR+/HER2-晚期或转移性乳腺癌的一线治疗。

今年2月，FDA进一步批准Ibrance联合阿斯利康肿瘤学药物Faslodex（fulvestrant，氟维司群），用于接受内分泌治疗后病情进展的HR+/HER2-晚期或转移性乳腺癌女性患者的治疗。此次批准，也标志着Ibrance治疗HR+/HER2-乳腺癌成功由一线治疗扩大至二线治疗，将显著扩大Ibrance的患者群体。

业界对Ibrance的商业前景也十分看好。此前，全球医药行业调研机构GlobalData发布报告指出，肿瘤学巨头罗氏（Roche）新推出的2种乳腺癌药物Perjeta和Kadcyla将助其继续称霸HER2+乳腺癌市场；辉瑞将凭借CDK4/6抑制剂Ibrance主导HER2-乳腺癌市场，该药在2023年的销售额将达到18.5亿美元；而阿斯利康将借助PARP抑制剂Lynparza主导三阴乳腺癌（TNBC）市场。

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2017-03-20 luwei00

#HER2-#

42 0
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2016-09-21 医生2402

#I期临床#

35 0
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2017-01-09 vera_1214

#临床一线#

37 0
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createdName=jjzouyan, createdTime=Tue Apr 26 14:56:00 CST 2016, time=2016-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82399, encodeId=f4c48239998, content=未来会统治这个领域！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/PiajxSqBRaELaQBNibpuZ0aRbWKgR0puf0vibBuZ7gIkKCXEqibYyJXVhsnibpCuhlqHGWRyvHMdFwm4UXjcpPUFLkw/0, createdBy=2f0f1714785, createdName=wxsession8b50a880, createdTime=Sun Apr 24 08:50:00 CST 2016, time=2016-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=81902, encodeId=46de819020f, content=价格多少, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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2016-10-03 1e10c84am36(暂无匿称)

深度好文，值得关注

61 0
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likeNumber=181, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Tue May 24 00:05:00 CST 2016, time=2016-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86758, encodeId=4e7386e5810, content=学习啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Sat May 21 13:10:00 CST 2016, time=2016-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82858, encodeId=44b482858c1, content=新药吗？新东西。, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue Apr 26 14:56:00 CST 2016, time=2016-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82399, encodeId=f4c48239998, content=未来会统治这个领域！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/PiajxSqBRaELaQBNibpuZ0aRbWKgR0puf0vibBuZ7gIkKCXEqibYyJXVhsnibpCuhlqHGWRyvHMdFwm4UXjcpPUFLkw/0, createdBy=2f0f1714785, createdName=wxsession8b50a880, createdTime=Sun Apr 24 08:50:00 CST 2016, time=2016-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=81902, encodeId=46de819020f, content=价格多少, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, 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2016-08-21 juliusluan78

#III#

33 0
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2016-05-24 1dedccb6m09(暂无匿称)

曲伐快不用了吧

181 0
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2016-05-21 1dedccb6m09(暂无匿称)

学习啦

71 0
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likeNumber=181, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Tue May 24 00:05:00 CST 2016, time=2016-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86758, encodeId=4e7386e5810, content=学习啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Sat May 21 13:10:00 CST 2016, time=2016-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82858, encodeId=44b482858c1, content=新药吗？新东西。, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue Apr 26 14:56:00 CST 2016, time=2016-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82399, encodeId=f4c48239998, content=未来会统治这个领域！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/PiajxSqBRaELaQBNibpuZ0aRbWKgR0puf0vibBuZ7gIkKCXEqibYyJXVhsnibpCuhlqHGWRyvHMdFwm4UXjcpPUFLkw/0, createdBy=2f0f1714785, createdName=wxsession8b50a880, createdTime=Sun Apr 24 08:50:00 CST 2016, time=2016-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=81902, encodeId=46de819020f, content=价格多少, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://q.qlogo.cn/qqapp/1103841572/894B687C2FA1EA915F4F0417CB01D727/100, createdBy=67bd1716731, createdName=QQ94a17e3e, createdTime=Sun Apr 24 07:33:00 CST 2016, time=2016-04-24, status=1, ipAttribution=)]
2016-04-26 jjzouyan

新药吗？新东西。

121 0
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createdAvatar=https://wx.qlogo.cn/mmopen/jW482SpianMayicTRbRZ5RzdAIB7UwTkHt6fQkBP8ictliaXtc5gCUmYdAW1sAETC2nhO3q6YjRHkUibyOCtP8ibmXNObTyd63A076/0, createdBy=d4111948983, createdName=1e10c84am36(暂无匿称), createdTime=Mon Oct 03 09:33:19 CST 2016, time=2016-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1915894, encodeId=a63a191589489, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sun Aug 21 03:52:00 CST 2016, time=2016-08-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86901, encodeId=56f08690172, content=曲伐快不用了吧, beContent=null, objectType=article, channel=null, level=null, likeNumber=181, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Tue May 24 00:05:00 CST 2016, time=2016-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86758, encodeId=4e7386e5810, content=学习啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Sat May 21 13:10:00 CST 2016, time=2016-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82858, encodeId=44b482858c1, content=新药吗？新东西。, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue Apr 26 14:56:00 CST 2016, time=2016-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82399, encodeId=f4c48239998, content=未来会统治这个领域！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/PiajxSqBRaELaQBNibpuZ0aRbWKgR0puf0vibBuZ7gIkKCXEqibYyJXVhsnibpCuhlqHGWRyvHMdFwm4UXjcpPUFLkw/0, createdBy=2f0f1714785, createdName=wxsession8b50a880, createdTime=Sun Apr 24 08:50:00 CST 2016, time=2016-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=81902, encodeId=46de819020f, content=价格多少, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://q.qlogo.cn/qqapp/1103841572/894B687C2FA1EA915F4F0417CB01D727/100, createdBy=67bd1716731, createdName=QQ94a17e3e, createdTime=Sun Apr 24 07:33:00 CST 2016, time=2016-04-24, status=1, ipAttribution=)]
2016-04-24 wxsession8b50a880

未来会统治这个领域！

115 0
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likeNumber=181, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Tue May 24 00:05:00 CST 2016, time=2016-05-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=86758, encodeId=4e7386e5810, content=学习啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=71, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=48091727242, createdName=1dedccb6m09(暂无匿称), createdTime=Sat May 21 13:10:00 CST 2016, time=2016-05-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82858, encodeId=44b482858c1, content=新药吗？新东西。, beContent=null, objectType=article, channel=null, level=null, likeNumber=121, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0d231626576, createdName=jjzouyan, createdTime=Tue Apr 26 14:56:00 CST 2016, time=2016-04-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=82399, encodeId=f4c48239998, content=未来会统治这个领域！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/PiajxSqBRaELaQBNibpuZ0aRbWKgR0puf0vibBuZ7gIkKCXEqibYyJXVhsnibpCuhlqHGWRyvHMdFwm4UXjcpPUFLkw/0, createdBy=2f0f1714785, createdName=wxsession8b50a880, createdTime=Sun Apr 24 08:50:00 CST 2016, time=2016-04-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=81902, encodeId=46de819020f, content=价格多少, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://q.qlogo.cn/qqapp/1103841572/894B687C2FA1EA915F4F0417CB01D727/100, createdBy=67bd1716731, createdName=QQ94a17e3e, createdTime=Sun Apr 24 07:33:00 CST 2016, time=2016-04-24, status=1, ipAttribution=)]
2016-04-24 QQ94a17e3e

价格多少

69 0

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