吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐

金吾财讯07-24 18:45

金吾财讯 | 吉利德科学(GILD)宣布，欧洲药品管理局(EMA)旗下人用药品委员会(CHMP)已发布积极意见，建议批准其Trop-2靶向ADC药物Trodelvy®联合帕博利珠单抗(Keytruda®)，用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性(CPS ≥ 10)的不可切除局部晚期或转移性三阴性乳腺癌(TNBC)成人患者。

据介绍，CHMP的这一推荐基于关键3期临床试验(ASCENT-04/KEYNOTE-D19)的优异结果：1)无进展生存期(PFS)：相比“标准化疗 + Keytruda®”的对照组，Trodelvy®与Keytruda®联合疗法展现出在统计学与临床意义上的显著改善；2）疾病控制率：联合疗法将患者的疾病进展或死亡风险大幅降低了 35%。

若欧盟委员会(EC)于2026年晚些时候正式批准该联合疗法，Trodelvy®将实现从单药到联合疗法、全面覆盖不同PD-L1表达状态的mTNBC一线治疗布局。此前，Trodelvy®单药已在欧盟获批用于不适合接受PD-(L)1抑制剂治疗的mTNBC一线患者，且在美国已获得FDA对于单药及联合疗法的全面许可。

据悉，作为全球首创的Trop-2靶向ADC，Trodelvy®已在超过75,000名患者中积累了丰富的临床应用经验。随着其在欧洲一线治疗领域的进一步拓展，吉利德在肿瘤精准治疗领域的商业化护城河与营收增长动能有望得到进一步巩固。

免责声明：本文观点仅代表作者个人观点，不构成本平台的投资建议，本平台不对文章信息准确性、完整性和及时性做出任何保证，亦不对因使用或信赖文章信息引发的任何损失承担责任。

精彩评论

我们需要你的真知灼见来填补这片空白

发表看法

{"i18n":{"language":"zh_CN"},"isChannel":false,"data":{"share":"https://www.laohu8.com/m/news/2653895100?lang=zh_CN&edition=full","thumbnail":"https://static.szfiu.com/news/20210810/NmQ4YmNlMWEyMTYyODU5MDQwMjQzMA==.jpg","is_english":false,"pubTime":"2026-07-24 18:45","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2653895100","market":"hk","top_or_hot":-1,"title":"吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐","media":"金吾财讯","content":"<html><body><p>金吾财讯 | <a href=\"https://laohu8.com/S/GILD\">吉利德科学</a>(GILD)宣布，欧洲药品管理局(EMA)旗下人用药品委员会(CHMP)已发布积极意见，建议批准其Trop-2靶向ADC药物Trodelvy®联合帕博利珠单抗(Keytruda®)，用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性(CPS ≥ 10)的不可切除局部晚期或转移性三阴性乳腺癌(TNBC)成人患者。</p><p>据介绍，CHMP的这一推荐基于关键3期临床试验(ASCENT-04/KEYNOTE-D19)的优异结果：1)无进展生存期(PFS)： 相比“标准化疗 + Keytruda®”的对照组，Trodelvy®与Keytruda®联合疗法展现出在统计学与临床意义上的显著改善；2）疾病控制率：联合疗法将患者的疾病进展或死亡风险大幅降低了 35%。</p><p>若欧盟委员会(EC)于2026年晚些时候正式批准该联合疗法，Trodelvy®将实现从单药到联合疗法、全面覆盖不同PD-L1表达状态的mTNBC一线治疗布局。此前，Trodelvy®单药已在欧盟获批用于不适合接受PD-(L)1抑制剂治疗的mTNBC一线患者，且在美国已获得FDA对于单药及联合疗法的全面许可。</p><p>据悉，作为全球首创的Trop-2靶向ADC，Trodelvy®已在超过75,000名患者中积累了丰富的临床应用经验。随着其在欧洲一线治疗领域的进一步拓展，<a href=\"https://laohu8.com/S/00175\">吉利</a>德在肿瘤精准治疗领域的商业化护城河与营收增长动能有望得到进一步巩固。</p></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\n吉利德科学(GILD)肿瘤组合疗法获欧洲药品管理局旗下CHMP推荐\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-07-24 18:45 北京时间&nbsp;&nbsp;&nbsp;<a href=302998><strong>金吾财讯</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>金吾财讯 | 吉利德科学(GILD)宣布，欧洲药品管理局(EMA)旗下人用药品委员会(CHMP)已发布积极意见，建议批准其Trop-2靶向ADC药物Trodelvy®联合帕博利珠单抗(Keytruda®)，用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性(CPS ≥ 10)的不可切除局部晚期或转移性三阴性乳腺癌(TNBC)成人患者。据介绍，CHMP的这一推荐基于关键3期临床试验(ASCENT-...</p>\n\n<a href=\"302998\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IBBQ","symbol_name":"Invesco Nasdaq Biotechnology ETF","start_time":0,"source_url":"302998","article_id":"2653895100","we_media_id":"1086022552","thumbnails":["https://static.szfiu.com/news/20210810/NmQ4YmNlMWEyMTYyODU5MDQwMjQzMA==.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2653895100","pubTimestamp":1784889935,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"金吾财讯","introduction":"「金吾财讯」以精准用户需求为切入点，打造一站式港美股投资细分领域品牌。依托战略合作伙伴凤凰网财经，将港美股内容传播到全球华人圈。","home_visible":1,"id":"1086022552","head_image":"https://static.tigerbbs.com/19a93586c3b023ec6ebfed568990555c"},"summary":"金吾财讯 | 吉利德科学 宣布，欧洲药品管理局旗下人用药品委员会已发布积极意见，建议批准其Trop-2靶向ADC药物Trodelvy联合帕博利珠单抗，用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性的不可切除局部晚期或转移性三阴性乳腺癌成人患者。若欧盟委员会于2026年晚些时候正式批准该联合疗法，Trodelvy将实现从单药到联合疗法、全面覆盖不同PD-L1表达状态的mTNBC一线治疗布局。","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"zh","relate_stocks":{"IBBQ":"Invesco Nasdaq Biotechnology ETF","MEDI":"HARBOR HEALTH CARE ETF","SG9999015978.USD":"利安颠覆性创新基金A","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","BIB":"Ultra纳斯达克生物科","BK4585":"ETF&股票定投概念","LU0823416689.USD":"BNP PARIBAS HEALTH CARE INNOVATORS \"C\" (USD) ACC","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU0122379950.USD":"贝莱德世界健康科学A2","BK4139":"生物科技","IBB":"生物科技指数ETF-iShares Nasdaq","TMED":"T. Rowe Price Health Care ETF","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","LU0058720904.USD":"联博国际健康护理基金A","BMED":"iShares Health Innovation Active ETF","LU0965509010.AUD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (AUDHDG) INC","LU2324357040.USD":"HSBC GIF GLOBAL EQUITY SUSTAINABLE HEALTHCARE \"AC\" (USD) ACC","LU1674673428.USD":"HSBC GIF GLOBAL LOWER CARBON EQUITY \"AC\" (USD) ACC","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","CHMP":"冠军工业","LU2089984988.USD":"MANULIFE GF HEALTHCARE \"AA\" (USD) ACC","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","BK4578":"CAR-T","BK4568":"美国抗疫概念","BK4550":"红杉资本持仓","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","LU0965508806.USD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (USD) INC","LU0889565916.HKD":"FRANKLIN BIOTECHNOLOGY DISCOVERY \"A\" (HKD) ACC","TBXU":"Direxion Daily Biotech Top 5 Bull 2X ETF","BBH":"VanEck Biotech ETF","BK4588":"碎股","LU1037948541.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (HKD) ACC","LU0234570918.USD":"高盛全球核心股票组合Acc Close","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","LU1934455194.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","GILD":"吉利德科学","LU1934455863.HKD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (HKD) ACC","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","BK4583":"猴痘概念","LU1061106388.HKD":"BGF WORLD HEALTHSCIENCE \"A2\" (HKDHDG) ACC","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","LU0965509101.SGD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (SGDHDG) ACC"},"translate_title":"Gilead Sciences (GILD) oncology combination therapy recommended by the CHMP of the European Medicines Agency","themeId":"299f0a9977df499f8ead781071e5e5e7","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IBB":0.6,"TBXU":0.6,"BBH":0.6,"BIB":0.6,"IBBQ":0.6,"TMED":0.6,"CHMP":1.5,"MEDI":0.6,"BMED":0.6,"GILD":1.5},"content_text":"金吾财讯 | 吉利德科学(GILD)宣布，欧洲药品管理局(EMA)旗下人用药品委员会(CHMP)已发布积极意见，建议批准其Trop-2靶向ADC药物Trodelvy®联合帕博利珠单抗(Keytruda®)，用于既往未接受过全身治疗、且肿瘤PD-L1表达阳性(CPS ≥ 10)的不可切除局部晚期或转移性三阴性乳腺癌(TNBC)成人患者。据介绍，CHMP的这一推荐基于关键3期临床试验(ASCENT-04/KEYNOTE-D19)的优异结果：1)无进展生存期(PFS)： 相比“标准化疗 + Keytruda®”的对照组，Trodelvy®与Keytruda®联合疗法展现出在统计学与临床意义上的显著改善；2）疾病控制率：联合疗法将患者的疾病进展或死亡风险大幅降低了 35%。若欧盟委员会(EC)于2026年晚些时候正式批准该联合疗法，Trodelvy®将实现从单药到联合疗法、全面覆盖不同PD-L1表达状态的mTNBC一线治疗布局。此前，Trodelvy®单药已在欧盟获批用于不适合接受PD-(L)1抑制剂治疗的mTNBC一线患者，且在美国已获得FDA对于单药及联合疗法的全面许可。据悉，作为全球首创的Trop-2靶向ADC，Trodelvy®已在超过75,000名患者中积累了丰富的临床应用经验。随着其在欧洲一线治疗领域的进一步拓展，吉利德在肿瘤精准治疗领域的商业化护城河与营收增长动能有望得到进一步巩固。","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"isLaohu8Offline":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.44.1","shortVersion":"4.44.1","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2653895100","isCrawlerRequest":true}