百濟神州(06160.HK)治療腫瘤藥物在終期分析中取得積極結果
百濟神州(06160.HK)公布,在全球3期ALPINE試驗的一項終期分析中,經獨立評審委員會(IRC)及研究者評估,百悅澤(澤布替尼)對比億珂(伊布替尼),取得無進展生存期(PFS)的優效性結果。澤布替尼總體耐受性良好,分析顯示的安全性結果與既往報告中一致。
百濟神州在美國遞交用於治療成人CLL或小淋巴細胞淋巴瘤(SLL)患者的新適應症上市許可申請目前正在審評中,FDA對該項申請做出決定的目標時間為2023年1月20日。
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