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微芯生物(688321.SH):西達本胺片獲藥品註冊批件
格隆匯 11-29 18:13

格隆匯11月29日丨微芯生物(688321.SH)公佈,公司和全資子公司深圳微芯藥業有限責任公司(以下簡稱“微芯藥業”)於2019年11月29日收到國家藥品監督管理局核准簽發的《藥品註冊批件》。

經審查,該藥品符合藥品註冊的有關要求,批准增加適應症:“聯合芳香化酶抑制劑用於激素受體陽性、人表皮生長因子受體-2陰性、絕經後、經內分泌治療復發或進展的局部晚期或轉移性乳腺癌患者。

表觀遺傳異常是腫瘤患者產生繼發耐藥的重要生物學基礎,西達本胺作為選擇性的表觀遺傳調控劑在前期的乳腺癌耐藥機制研究中展示出可以改善耐藥並增敏已有治療藥物的作用。在已完成的入組人羣為絕經後雌激素受體陽性、HER-2陰性、經既往內分泌治療(輔助或解救)復發/轉移的晚期乳腺癌患者的關鍵性III期臨牀試驗中,西達本胺聯合依西美坦與單用依西美坦相比,可顯著延長患者的無進展生存期(PFS),其中在有內臟轉移的患者中差異更明顯。同時,西達本胺聯合依西美坦在客觀緩解率、臨牀獲益率方面均優於安慰劑聯合依西美坦。不良反應特點與既往使用西達本胺單藥報道相似,大部分患者可以耐受。這是在全球首次確證HDAC抑制劑聯合其他靶向藥物可以有效改善腫瘤耐藥並進一步增敏對靶向藥物的療效,西達本胺聯合依西美坦為既往內分泌治療復發/進展晚期乳腺癌患者提供了一種更優的治療選擇。

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