辉瑞(PFE.US)CD3/BCMA双抗拟优先审评！用于复发或难治性多发性骨髓瘤治疗

智通财经03-18

智通财经APP获悉，3月18日，据CDE官网显示，拟将辉瑞(PFE.US)CD3/BCMA双抗Elranatamab上市申请纳入优先审评，用于既往接受过至少三种治疗(含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体)的复发或难治性多发性骨髓瘤成人患者的治疗。Elranatamab(ELREXFIO)是全球获批上市的第二款BCMA/CD3双特异性抗体，于去年8月14日获美国FDA加速...

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Used for the treatment of relapsed or refractory multiple myeloma","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"PFE":1},"content_text":"智通财经APP获悉，3月18日，据CDE官网显示，拟将辉瑞(PFE.US)CD3/BCMA双抗Elranatamab上市申请纳入优先审评，用于既往接受过至少三种治疗(含一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单克隆抗体)的复发或难治性多发性骨髓瘤成人患者的治疗。Elranatamab(ELREXFIO)是全球获批上市的第二款BCMA/CD3双特异性抗体，于去年8月14日获美国FDA加速批准，治疗既往接受过至少4种疗法(包括一种蛋白酶体抑制剂、一种免疫调节剂和一种抗CD38单抗)的复发性或难治性多发性骨髓瘤(R/RMM)成人患者。公开资料显示，在美国的获批基于单臂II期MagnetisMM-3研究(登记号：NCT04649359)的积极结果。在接受Elranatamab治疗前曾接受4线或更多线数治疗患者(n=97)的ORR为58%，估计82%的患者维持至少9个月的缓解，首次出现缓解的中位时间为1.2个月。据Insight数据库显示，当前全球共26款CD3/BCMA双抗在研，除了已上市的Teclistamab(强生/Genmab)和Elranatamab(辉瑞)之外，Linvoseltamab(再生元/赛诺菲)也已经申报上市，另有2款处于III期临床阶段。中国企业参与的项目也有16款，不过仍处于早期开发中。","kind":null,"is_publish_news":null,"is_publish_highlight":null,"is_publish_live":null,"is_publish_wemedia":null,"editions":null,"symbols":[],"gpt_button":1},"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,"deviceId":"web-server-community-laohu8-v3","version":"4.22.4","shortVersion":"4.22.4","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/2420422854"}