百时美施贵宝（Bristol Myers Squibb）周五宣布，欧盟委员会（EC）已批准Breyanzi®（利基迈仑赛）用于治疗接受过两线或以上系统治疗后复发或难治性滤泡性淋巴瘤（FL）的成年患者。

　　该决定基于全球2期TRANSCEND FL试验的结果，这是迄今为止评估CAR-T细胞疗法在复发或难治性惰性非霍奇金淋巴瘤（NHL）患者中疗效的最大规模临床试验。

　　Breyanzi显示出持久的临床效益，75.7%的患者在18个月时仍有反应，且安全性一致，未观察到新的安全信号。

　　百时美施贵宝欧洲地区高级副总裁艾玛·查尔斯（Emma Charles）表示：“Breyanzi在佛罗里达州之外得到额外批准，标志着我们在向欧洲更多患者提供细胞疗法变革性承诺的使命中迈出了关键一步。”

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责任编辑：张俊 SF065

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