信达生物(01801)：达伯舒® 联合爱优特® 获中国国家药监局批准用于治疗晚期或转移性肾细胞癌患者

智通财经05-21 16:56

智通财经APP讯，信达生物(01801)公布，达伯舒^® (信迪利单抗注射液)和爱优特^® (呋喹替尼)的联合疗法的新药上市申请获中国国家药品监督管理局批准，用于治疗既往接受血管内皮生长因子受体-酪氨酸激酶抑制剂(VEGFR-TKI)治疗失败且一线未接受程序性死亡受体-1(PD-1)或程序性死亡配体-1(PD-L1)抑制剂的局部晚期或转移性肾细胞癌患者。

此项批准是基于FRUSICA-2研究的数据支持。FRUSICA-2是一项随机、开放卷标、阳性对照的注册研究，旨在评估信迪利单抗和呋喹替尼联合疗法对比阿昔替尼(axitinib)或依维莫司(everolimus)单药疗法用于二线治疗晚期肾细胞癌的疗效和安全性。该研究已达到盲态独立中心阅片(BICR)评估的无进展生存期(PFS)主要终点。

此次获批对中国晚期肾细胞癌患者而言是一个重要的里程碑。它进一步验证了信迪利单抗和呋喹替尼联合疗法的潜力，目前已在两种难治的癌症中获批。公司也为达伯舒^® (信迪利单抗注射液)的第十项适应症获批感到自豪，并将继续致力于提升其临床价值，以造福更广泛的癌症患者群体。

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