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基石藥業-B(02616.HK)披露治療白血病藥物臨床數據
阿思達克 04-22 08:57
基石藥業-B(02616.HK)公布,《新英格蘭醫學雜誌》發表了拓舒沃(R)(艾伏尼布片)AGILE III期臨床研究結果。AGILE研究是一項全球III期、多中心、雙盲、隨機、安慰劑對照的臨床試驗,旨在評估拓舒沃(R)聯合阿紮胞(甘)相較于安慰劑聯合阿紮胞(甘)在先前未經治療的異檸檬酸脫氫(酉每)-1(IDH1)突變急性髓系白血病(AML)患者中的療效和安全性。 AGILE研究達到了主要研究終點和包括總生存期(OS)在內的所有關鍵次要終點。施維雅公司正在積極與包括美國食品藥品監督管理局(FDA)在內的多個國家和地區的藥品監督管理部門就拓舒沃該新適應症上市申請展開溝通。基石藥業計劃在中國遞交拓舒沃該適應症的新藥上市申請。
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