AbbVie申请将Venclexta组合疗法推进到CLL一线治疗AbbVie files to move Venclexta combo into the CLL front line

动脉网2025-07-30

AbbVie has filed for approval of a regimen based on its Venclexta therapy for previously untreated patients with chronic lymphocytic leukaemia (CLL), in combination with an AstraZeneca drug.AbbVie已为其...

网页链接

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/2555042530?lang=zh_CN&edition=full","thumbnail":"","is_english":false,"pubTime":"2025-07-30 21:18","share_image_url":"https://static.laohu8.com/9a95c1376e76363c1401fee7d3717173","id":"2555042530","market":"us","top_or_hot":-1,"title":"AbbVie申请将Venclexta组合疗法推进到CLL一线治疗AbbVie files to move Venclexta combo into the CLL front line","media":"动脉网","content":"<div>\n<p>AbbVie has filed for approval of a regimen based on its Venclexta therapy for previously untreated patients with chronic lymphocytic leukaemia (CLL), in combination with an AstraZeneca drug.AbbVie已为其...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025073021191294c3f0a1&s=b\">网页链接</a>\n\n</div>\n","source":"tencent","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>AbbVie申请将Venclexta组合疗法推进到CLL一线治疗AbbVie files to move Venclexta combo into the CLL front line</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\">\nAbbVie申请将Venclexta组合疗法推进到CLL一线治疗AbbVie files to move Venclexta combo into the CLL front line\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-07-30 21:18 北京时间&nbsp;&nbsp;&nbsp;<a href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025073021191294c3f0a1&s=b><strong>动脉网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>AbbVie has filed for approval of a regimen based on its Venclexta therapy for previously untreated patients with chronic lymphocytic leukaemia (CLL), in combination with an AstraZeneca drug.AbbVie已为其...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025073021191294c3f0a1&s=b\">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":"LU0234570918.USD","symbol_name":"高盛全球核心股票组合Acc Close","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025073021191294c3f0a1&s=b","article_id":"2555042530","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025073021191294c3f0a1&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2555042530","pubTimestamp":1753881480,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"AbbVie has filed for approval of a regimen based on its Venclexta therapy for previously untreated patients with chronic lymphocytic leukaemia , in combination with an AstraZeneca drug.AbbVie已为其基于Venclexta疗法的方案申请批准，用于既往未经治疗的慢性淋巴细胞白血病患者，该方案与阿斯利康的一种药物联合使用。Calquence, meanwhile, is already approved for first-line CLL, but with a label that calls for treatment until disease progression, and approval based on the AMPLIFY data would allow patients to take a holiday from treatment, potentially reducing long-term side effects.Calquence 已经被批准用于一线 CLL 治疗，但其标签上要求持续治疗直到疾病进展，而基于 AMPLIFY 数据的批准将允许患者暂停治疗，这可能会减少长期副作用。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0234570918.USD":"高盛全球核心股票组合Acc Close","IE00BGHQF631.EUR":"GUINNESS GLOBAL EQUITY INCOME \"C\" (EUR) ACC","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","AZ":"A2Z Cust2Mate Solutions Corp","LU0985320562.USD":"NORDEA 1 GLOBAL STARS EQUITY \"BP\" (USD) ACC","LU0417517546.SGD":"Allianz US Equity Cl AT Acc SGD","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","LU1934455194.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"A\" (USD) ACC","LU1718418525.SGD":"JPMorgan Investment Funds - Global Select Equity A (acc) SGD","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","LU0912757837.SGD":"JPMorgan Investment Funds - Global Income A (mth) SGD-H","LU0661504455.SGD":"Blackrock Global Equity Income A5 SGD-H","LU0256863902.USD":"ALLIANZ US EQUITY \"AT\" (USD) ACC","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BDGV0183.EUR":"GUINNESS GLOBAL EQUITY INCOME \"C\" (EUR) INC","LU0738911758.USD":"Blackrock Global Equity Income A6 USD","IE00BFTCPJ56.SGD":"Janus Henderson Global Life Sciences A Acc SGD","LU2347655156.SGD":"JPMorgan Investment Funds - Global Income A (icdiv) SGD-H","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4566":"资本集团","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","LU2089284900.SGD":"Allianz Global Sustainability Cl AM Dis H2-SGD","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU1983299246.USD":"SCHRODER ISF HEALTHCARE INNOVATION \"A\" (USD) ACC","LU2129689431.USD":"FRANKLIN GLOBAL INCOME \"A\" (USD) ACC","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","OS":"OneStream, Inc.","LU1244550577.SGD":"FTIF - Franklin Global Multi-Asset Income A (Mdis) SGD-H1","BK4550":"红杉资本持仓","ABBV":"艾伯维公司","LU1003077747.HKD":"BGF GLOBAL EQUITY INCOME \"A6\" (HKDHDG) INC","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","LU2237443382.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA USD","LU1989772840.SGD":"CPR Invest - Climate Action A2 Acc SGD-H","LU1551013425.SGD":"Allianz Income and Growth Cl AMg2 DIS H2-SGD","IE0009355771.USD":"骏利亨德森环球生命科技A Acc","LU2237443549.SGD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A MIncA SGD-H","LU1732800096.USD":"摩根大通环球收益基金A (irc)","SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","LU1037948897.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"AD\" (HKD) INC","LU1093756168.USD":"FRANKLIN K2 ALTERNATIVE STRATEGIES \"A\" (USD) ACC","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU2237443465.HKD":"abrdn SICAV I -  GLOBAL DYNAMIC DIVIDEND \"A\" (HKD) INC","LU1267930573.SGD":"TEMPLETON GLOBAL \"AA\" (SGD) ACC A","LU1732799900.SGD":"JPMorgan Investment Funds - Global Income A (irc) SGD-H","LU1934455277.USD":"AB SICAV I LOW VOLATILITY TOTAL RETURN EQUITY PORT \"AD\" (USD) INC","LU0158827948.USD":"ALLIANZ GLOBAL SUSTAINABILITY \"A\" (USD) INC","BK4581":"高盛持仓","LU1037948541.HKD":"AB LOW VOLATILITY EQUITY PORTFOLIO \"A\" (HKD) ACC"},"translate_title":"AbbVie files to advance Venclexta combination therapy to first-line treatment of CLL AbbVie files to move Venclexta combo into the CLL front line","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AZ":1,"ABBV":0.9,"OS":1},"content_text":"AbbVie has filed for approval of a regimen based on its Venclexta therapy for previously untreated patients with chronic lymphocytic leukaemia (CLL), in combination with an AstraZeneca drug.AbbVie已为其基于Venclexta疗法的方案申请批准，用于既往未经治疗的慢性淋巴细胞白血病（CLL）患者，该方案与阿斯利康的一种药物联合使用。The filing is supported by the AMPLIFY trial, which paired Roche-partnered BCL-2 inhibitor该文件得到了AMPLIFY试验的支持，该试验与罗氏合作的BCL-2抑制剂配对。Venclexta维奈克拉(venetoclax) with AZ's BTK inhibitor Calquence (acalabrutinib) in CLL patients without del(17p) or TP53 mutations, comparing them to standard chemoimmunotherapy (CIT).将AZ的BTK抑制剂Calquence（acalabrutinib）与维奈托克（venetoclax）联合用于无del(17p)或TP53突变的CLL患者，并与标准化学免疫疗法（CIT）进行比较。If approved, the dual regimen could become an all-oral, fixed-duration first-line treatment for CLL, and inject further growth into Venclexta, which remains one of AbbVie's top-selling products with turnover of almost $2.6 billion last year.如果获得批准，这种双重疗法可能成为CLL的全口服、固定疗程的一线治疗方案，并为维奈托克注入进一步的增长动力。维奈托克仍然是艾伯维最畅销的产品之一，去年的销售额接近26亿美元。In AMPLIFY, Venclexta/Calquence reduced the risk of disease progression or death by 35% compared to CIT, with a trend towards improved overall survival (OS) that the two companies hope may mature into a significant improvement.在AMPLIFY试验中，与CIT相比，Venclexta/Calquence降低了35%的疾病进展或死亡风险，并且有改善总生存期（OS）的趋势，两家公司希望这可能发展为显著的改善。Venclexta has been on the market since 2016 for CLL, initially for 17p-mutated cases, and since 2019 has been used as a first-line option in combination with Roche's Gazyva (obinutuzumab) as a chemotherapy-free therapy for treatment-naïve patients.自2016年以来，Venclexta一直用于CLL治疗，最初适用于17p突变的病例，并且自2019年以来，已与罗氏的Gazyva（奥比妥珠单抗）联用，作为无需化疗的疗法，成为初治患者的首选方案。Calquence, meanwhile, is already approved for first-line CLL, but with a label that calls for treatment until disease progression, and approval based on the AMPLIFY data would allow patients to take a holiday from treatment, potentially reducing long-term side effects.Calquence 已经被批准用于一线 CLL 治疗，但其标签上要求持续治疗直到疾病进展，而基于 AMPLIFY 数据的批准将允许患者暂停治疗，这可能会减少长期副作用。Its main rival in the BTK category is BeOne's其在BTK类别中的主要竞争对手是BeOne的Brukinsa布鲁金萨(zanubrutinib), which was given the go-ahead for front-line CLL treatment in 2023 based on the SEQUOIA trial results and has been growing quickly to reach $3.8 billion last year, overtaking the $3.1 billion made by AZ's drug.（泽布替尼）于2023年基于SEQUOIA试验结果获批用于一线CLL治疗，并迅速增长，去年达到38亿美元，超过了阿斯利康药物的31亿美元。Brukinsa's growth is tied to data showing it was布鲁金萨的增长与数据表明其more effective更有效in CLL than AbbVie's first-generation BTK inhibitor Imbruvica (ibrutinib) – partnered with Johnson & Johnson – while Calquence was only able to show non-inferiority in its head-to-head trial.在CLL中，与强生合作的AbbVie的第一代BTK抑制剂Imbruvica（ibrutinib）相比，而Calquence在其头对头试验中仅能显示非劣效性。For AZ, the hope is that the fixed-duration regimen can allow it to re-establish an edge in the market, as Brukinsa's label also calls for it to be dosed until disease progression.对于阿斯利康（AZ）来说，希望固定疗程的方案能够帮助其重新在市场上占据优势，因为百悦泽（Brukinsa）的说明书也要求用药直至疾病进展。CLL is the most prevalent type of leukaemia in adults worldwide and, while it is considered incurable, patients often live with the disease for many years and may remain on continuous treatment.CLL是全球成人中最普遍的白血病类型，虽然它被认为无法治愈，但患者通常可以与疾病共存多年，并可能持续接受治疗。'This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of Venclexta and acalabrutinib for previously untreated patients with chronic blood cancer,' said Svetlana Kobina, vice president, global medical affairs for oncology, at AbbVie..“这份FDA提交的文件标志着CLL治疗的一个里程碑，有望批准首个维奈托克和阿卡替尼布的口服联合方案，用于既往未经治疗的慢性血癌患者，”艾伯维公司肿瘤学全球医学事务副总裁斯韦特兰娜·科宾娜表示。'This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care.'“这种新的固定治疗持续时间方法如果获得批准，可让患者有机会暂停治疗，并有可能改变一线CLL护理的实践。”","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":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,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2555042530","isCrawlerRequest":true}