艾力斯(688578.SH):甲磺酸伏美替尼片獲批臨牀試驗
格隆匯1月11日丨艾力斯(688578.SH)公佈,公司及子公司江蘇艾力斯生物醫藥有限公司於近日收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》。
本次獲批開展甲磺酸伏美替尼(以下簡稱“伏美替尼”)應用於表皮生長因子受體(EGFR)突變陽性的II-IIIA期非小細胞肺癌患者術後輔助治療的臨牀試驗,具體為:在接受根治性切除伴或不伴輔助化療後的表皮生長因子受體(EGFR)突變陽性II-IIIA期非小細胞肺癌患者中比較伏美替尼與安慰劑療效和安全性的隨機、雙盲、安慰劑對照的多中心III期研究。
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