罗氏(RHHBY.US)格菲妥单抗新适应症在华获批

智通财经
May 08

智通财经APP获悉,5月7日,罗氏(RHHBY.US)(Roche)宣布格菲妥单抗注射液新适应症上市申请已获得中国国家药监局(NMPA)批准,联合吉西他滨与奥沙利铂(GemOx)用于治疗不适合自体造血干细胞移植(ASCT)的复发或难治性弥漫大B细胞淋巴瘤非特指型(DLBCL NOS)成人患者(2L+ DLBCL)。格菲妥单抗(glofitamab,商品名:Columvi)是一款靶向CD20和CD3的双特异性T细胞衔接蛋白

格菲妥单抗是一类无需定制化的即用型T细胞疗法,依托新型的2:1双抗结构,可同时靶向结合2种抗原分子——T细胞表面的CD3抗原和B细胞表面的CD20抗原,激活、扩增、重定向T细胞的同时,可带来更强的B细胞抓取能力和作用效力,在安全耐受的前提下加强杀伤肿瘤细胞的能力。因此,这一疗法可以帮助患者获得早期、深度的缓解,减小疾病进展风险。

2023年6月,美国FDA宣布加速批准glofitamab用于复发或难治DLBCL或由滤泡性淋巴瘤引起的大B细胞性淋巴瘤(LBCL)成年患者的治疗,这些患者经过二线或多线的系统治疗(3L+DLBCL)。该产品于2023年11月在中国获批上市,用于治疗既往接受过至少两线系统性治疗的复发或难治性DLBCL成人患者

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