智通财经APP获悉，9月23日，药品审评中心(CDE)网站显示，艾伯维(ABBV.US)的艾可瑞妥单抗注射液(epcoritamab)在华申报新适应症。根据优先审评进展，本次申报的适应症为联合利妥昔单抗和来那度胺治疗复发或难治性滤泡性淋巴瘤(FL)成人患者。

艾可瑞妥单抗是Genmab利用其专有的DuoBody技术开发的一款IgG1双特异性抗体，可同时靶向T细胞上的CD3和B细胞上的CD20，诱导T细胞杀伤CD20+细胞。

8月7日， 一项评估艾可瑞妥单抗联合利妥昔单抗+来那度胺对比利妥昔单抗+来那度胺方案，用于成人复发或难治性滤泡性淋巴瘤(R/R FL)患者的疗效与安全性的III期研究(EPCORE FL-1研究)取得积极结果。预设中期分析显示，该研究已达到ORR和PFS双重主要终点。

艾可瑞妥单抗联合治疗组的ORR达95.7%(p<0.0001)，PFS风险比(HR)为0.21(p<0.0001)，疾病进展或死亡风险降低79%。美国FDA已受理艾可瑞妥单抗用于该适应症的sBLA并授予优先审评资格，PDUFA日期为2025年11月30 日。

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