FDA批准百時美施貴寶(BMY.US)Opdivo+Yervoy聯合治療結直腸癌

智通財經網

04-09

百時美施貴寶(BMY.US)週二表示，美國食品藥品管理局(FDA)已批准其重磅PD-1抑制劑Opdivo(nivolumab)聯合CTLA-4靶向抗體Yervoy(ipilimumab)用於治療微衛星高度不穩定(MSI-H)或錯配修復缺陷(dMMR)表型的轉移性結直腸癌(mCRC)成人和兒童患者。

百時美施貴寶在1月底公佈了3期臨牀試驗CheckMate-8HW的分析結果。該研究評估了Opdivo聯合Yervoy，對比研究者選擇的化療(mFOLFOX-6或FOLFIRI方案，聯合或不聯合貝伐珠單抗或西妥昔單抗)用於治療微衛星高度不穩定(MSI-H)或錯配修復缺陷(dMMR)表型的轉移性結直腸癌(mCRC)患者。分析顯示，在中位隨訪47個月時，接受Opdivo聯合Yervoy治療的患者在所有治療線中，相較於Opdivo單藥療法，疾病進展或死亡的風險降低了38%。此前，CheckMate-8HW試驗的結果顯示，相較於研究者選擇的化療，Opdivo聯合Yervoy可將疾病進展或死亡的風險降低79%。

Opdivo是一種PD-1免疫檢查點抑制劑，旨在幫助恢復抗腫瘤免疫反應，利用人體自身的免疫系統來對抗癌症。Yervoy則靶向抑制CTLA-4，CTLA-4抗體通過增強T細胞活性來提高腫瘤殺傷能力;該產品已於2011年獲得美國FDA批准治療晚期黑色素瘤，是全球首個獲批上市的CTLA-4抗體藥物。

海量資訊、精準解讀，盡在新浪財經APP

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src=\"\"/></div>\n<div>海量資訊、精準解讀，盡在新浪財經APP</div>\n</div>\n</div></body></html>","source":"sina","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>FDA批准百時美施貴寶(BMY.US)Opdivo+Yervoy聯合治療結直腸癌</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{ 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class=\"title\">\nFDA批准百時美施貴寶(BMY.US)Opdivo+Yervoy聯合治療結直腸癌\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">智通財經網</strong><span class=\"h-time small\">2025-04-09 14:48</span>\n</p>\n</h4>\n</header>\n<article>\n<html><body><div>\n<p cms-style=\"font-L\">百時美<a href=\"https://laohu8.com/S/BMY\">施貴寶</a>(BMY.US)週二表示，美國食品藥品管理局(FDA)已批准其重磅PD-1抑制劑Opdivo(nivolumab)聯合CTLA-4靶向抗體Yervoy(ipilimumab)用於治療微衛星高度不穩定(MSI-H)或錯配修復缺陷(dMMR)表型的轉移性結直腸癌(mCRC)成人和兒童患者。</p><p cms-style=\"font-L\">百時美施貴寶在1月底公佈了3期臨牀試驗CheckMate-8HW的分析結果。該研究評估了Opdivo聯合Yervoy，對比研究者選擇的化療(mFOLFOX-6或FOLFIRI方案，聯合或不聯合貝伐珠單抗或西妥昔單抗)用於治療微衛星高度不穩定(MSI-H)或錯配修復缺陷(dMMR)表型的轉移性結直腸癌(mCRC)患者。分析顯示，在中位隨訪47個月時，接受Opdivo聯合Yervoy治療的患者在所有治療線中，相較於Opdivo單藥療法，疾病進展或死亡的風險降低了38%。此前，CheckMate-8HW試驗的結果顯示，相較於研究者選擇的化療，Opdivo聯合Yervoy可將疾病進展或死亡的風險降低79%。</p><p cms-style=\"font-L\">Opdivo是一種PD-1免疫檢查點抑制劑，旨在幫助恢復抗腫瘤免疫反應，利用人體自身的免疫系統來對抗癌症。Yervoy則靶向抑制CTLA-4，CTLA-4抗體通過增強T細胞活性來提高腫瘤殺傷能力;該產品已於2011年獲得美國FDA批准治療晚期黑色素瘤，是全球首個獲批上市的CTLA-4抗體藥物。</p>\n<div>\n<div><img src=\"\"/></div>\n<div>海量資訊、精準解讀，盡在新浪財經APP</div>\n</div>\n</div></body></html>\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"https://finance.sina.com.cn/stock/hkstock/hkstocknews/2025-04-09/doc-inespyiw4103840.shtml\">智通財經網</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0237698245.USD","symbol_name":"富達環球地產基金A","start_time":0,"source_url":"https://finance.sina.com.cn/stock/hkstock/hkstocknews/2025-04-09/doc-inespyiw4103840.shtml","article_id":"2526811443","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2526811443","pubTimestamp":1744181280,"columns":[],"sourceInfo":{"source_id":"sina","name":"sina"},"weMediaInfo":null,"summary":"百時美施貴寶週二表示，美國食品藥品管理局已批准其重磅PD-1抑制劑Opdivo聯合CTLA-4靶向抗體Yervoy用於治療微衞星高度不穩定或錯配修復缺陷表型的轉移性結直腸癌成人和兒童患者。百時美施貴寶在1月底公佈了3期臨牀試驗CheckMate-8HW的分析結果。分析顯示，在中位隨訪47個月時，接受Opdivo聯合Yervoy治療的患者在所有治療線中，相較於Opdivo單藥療法，疾病進展或死亡的風險降低了38%。","collect":0,"end_time":0,"defaultTopTitle":"sina.com.cn","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0237698245.USD":"富达环球地产基金A","LU1868837300.USD":"CT 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