信達生物(01801.HK):國家藥監局受理信迪利單抗聯合呋喹替尼用於治療晚期腎細胞癌的新藥上市申請
格隆匯6月5日丨信達生物(01801.HK)發佈公告,中國國家藥品監督管理局(“NMPA”)已經正式受理信迪利單抗和呋喹替尼聯合療法的新藥上市申請(“NDA”),用於治療既往接受過一種酪氨酸激酶抑制劑(“TKI”)治療失敗的局部晚期或轉移性的腎細胞癌患者。
FRUSICA-2研究的數據支持了此項NDA。FRUSICA-2是一項隨機、開放式標籤、陽性對照的註冊研究,旨在評估信迪利單抗和呋喹替尼聯合療法對比阿昔替尼(axitinib)或依維莫司(everolimus)單藥療法用於二線治療晚期腎細胞癌的療效和安全性。該研究已達到盲態獨立中心閱片(BICR)根據RECIST 1.1標準評估的無進展生存期(“PFS”)的主要終點。該聯合療法亦在包括客觀緩解率(“ORR”)和緩解持續時間(“DoR”)在內的次要終點上亦取得改善。安全性特徵可耐受,亦未觀察到新的安全性信號。FRUSICA-2研究的數據將提交於近期的學術會議上發表。
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