貝達藥業(300558.SZ):埃克替尼用於術後輔助治療上市許可申請獲受理
格隆匯9月22日丨貝達藥業(300558.SZ)宣佈,近日,公司收到國家藥品監督管理局簽發的《受理通知書》(受理號:CXHS2000030國),公司申報的鹽酸埃克替尼(商品名:凱美納®,下稱“埃克替尼”)用於術後輔助治療的新適應症上市許可申請已獲國家藥品監督管理局受理。
埃克替尼是公司自主研發的我國第一個擁有自主知識產權的小分子靶向抗癌藥,其療效確切、肝毒性低、安全性高,循證醫學臨牀證據豐富,中國人羣數據全,在CSCO指南、衞健委診療規範及腦轉移人羣、21-L858R NSCLC患者中獲優先推薦,也是目前唯一繼續開展後續免費用藥項目的一代EGFR-TKI原研藥,具有明顯的差異化優勢。
目前,埃克替尼擁有兩項適應症:①單藥適用於治療表皮生長因子受體(EGFR)基因具有敏感突變的局部晚期或轉移性非小細胞肺癌患者的一線治療;②單藥可試用於治療既往接受過至少一個化療方案失敗後的局部晚期或轉移性非小細胞肺癌,既往化療主要是指以鉑類為基礎的聯合化療。
此次埃克替尼用於EGFR基因敏感突變的NSCLC患者術後輔助治療適應症的上市許可申請的依據是EVIDENCE研究,該項研究是針對Ⅱ-IIIA期肺癌EGFR突變患者術後輔助治療的對照試驗,試驗組為埃克替尼治療,對照組為標準輔助化療。該項目歷時近6年,研究結果顯示埃克替尼的療效優於標準輔助化療,能顯著延長患者無病生存期,同時安全性更優。
截至該公告日,國內尚無經批准用於EGFR基因敏感突變NSCLC患者術後輔助治療的EGFR-TKI靶向藥。
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