科倫藥業(002422.SZ):子公司核心產品蘆康沙妥珠單抗(sac-TMT)的新增適應症上市申請(sNDA)獲國家藥監局受理
格隆匯5月22日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司(以下簡稱"科倫博泰")靶向人滋養細胞表面抗原 2(TROP2)的抗體偶聯藥物(ADC)蘆康沙妥珠單抗(sac-TMT,亦稱SKB264/MK-2870)(佳泰萊®)的一項新增適應症上市申請(以下簡稱"該申請")已獲中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理,用於治療既往接受過內分泌治療且在晚期或轉移性階段接受過其他系統治療的不可切除的局部晚期或轉移性激素受體陽性(HR+)且人表皮生長因子受體 2 陰性(HER2-)乳腺癌(BC)成人患者。本次受理是基於 OptiTROP-Breast02 註冊 3 期研究的積極結果。該申請是蘆康沙妥珠單抗(sac-TMT)獲 NMPA 受理的第四個適應症上市申請。
OptiTROP-Breast02 是一項隨機、開放標籤、多中心 3 期臨牀研究,評估蘆康沙妥珠單抗(sac-TMT)單一療法(5mg/kg 每兩週一次(Q2W))對比研究者選擇化療方案用於治療局部晚期或轉移性 HR+/HER2- (免疫組織化學[IHC]0、IHC 1+或IHC 2+/原位雜交[ISH]-) BC 患者的有效性和安全性。根據預設的期中分析,該 3期臨牀研究達到主要療效終點,與研究者選擇化療方案相比,蘆康沙妥珠單抗(sac-TMT)單一療法在主要終點由盲態獨立評審委員會(BIRC)評估的無進展生存期(PFS)方面具有顯著統計學意義和臨牀意義的改善,顯著降低疾病進展或死亡風險。同時,蘆康沙妥珠單抗(sac-TMT)顯示出總生存期(OS)獲益趨勢。
2025 年 5 月 16 日,CDE 官網公佈,該申請擬納入 CDE 的優先審評審批程序。這是繼蘆康沙妥珠單抗(sac-TMT)前三項適應症上市申請納入優先審評審批程序後,第四項適應症上市申請納入 CDE 的優先審評審批程序。
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