美国食品和药物管理局批准Epkinly组合治疗复发性卵泡淋巴瘤, 显示进展风险降低了79%. FDA approves Epkinly combo for relapsed follicular lymphoma, showing 79% lower progression risk.

根据EPCORE FL-1试验显示,与标准治疗相比,Genmabs Epkinly (epcoritamab-bysp) 与列纳利多米德和利图西玛结合使用对复发性或耐药性卵泡淋巴瘤的成年人有显著改善的无进展生存率和整体反应率. The FDA has approved Genmab’s Epkinly (epcoritamab-bysp) in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma, based on the EPCORE FL-1 trial showing significantly improved progression-free survival and overall response rates compared to standard therapy. 合并后,疾病增加或死亡的风险降低了79%,控制组的中位PFS未达到中位数,即11.2个月,而ORR为89%,即74%。 The combination reduced the risk of disease progression or death by 79%, with a median PFS not reached versus 11.2 months in the control group and an ORR of 89% versus 74%. 该药是双性T细胞注射者,在2024年得到快速批准。 The drug, a bispecific T-cell engager, is administered subcutaneously and previously received accelerated approval in 2024. 美国食品和药物管理局也批准了Epkinly单一治疗的传统批准,用于两次或更多次治疗的患者. The FDA also granted traditional approval for Epkinly monotherapy in patients with two or more prior treatments. 常见副作用包括细胞素释放综合征、感染和细胞本科症,并用拳击警告与免疫有关的严重反应。 Common side effects include cytokine release syndrome, infections, and cytopenias, with boxed warnings for serious immune-related reactions.