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百濟神州(06160.HK)宣佈FDA已受理百悦澤®針對邊緣區淋巴瘤的新適應症上市申請並授予優先審評
格隆匯 05-20 12:26

格隆匯5月20日丨百濟神州(06160.HK)於2021年5月19日(美國東部時間)宣佈,美國食品藥品監督管理局(FDA)已受理百悦澤®(澤布替尼)用於治療先前接受過至少一項CD20導向療法的成年邊緣區淋巴瘤(MZL)患者的新適應症上市申請(sNDA)並授予其優先審評資格。處方藥申報者付費法案(PDUFA)日期為2021年9月19日。

百濟神州血液學首席醫學官黃蔚娟醫學博士表示:“這是公司針對邊緣區淋巴瘤提交的首項藥政申請。在美國,每年有2,000多人被診斷出患有邊緣區淋巴瘤,但卻沒有統一的標準療法。百悦澤®在針對邊緣區淋巴瘤的臨牀試驗中顯示出鼓舞人心的有效性和耐受性,為這些患者提供了一款潛在的全新治療選擇。我們會在接下來的幾個月中不斷與FDA進行溝通,繼續推進針對百悦澤®這款潛在同類最佳BTK抑制劑的廣泛的全球臨牀開發項目。

該項sNDA的臨牀數據來自一項百悦澤®用於治療復發或難治性MZL患者的單臂、開放性、多中心2期MAGNOLIA臨牀試驗(NCT03846427)結果(於2020年12月在美國血液學年會中公佈),以及一項百悦澤®針對B細胞惡性腫瘤的全球1/2期臨牀試驗(NCT02343120)的支援性數據。同時,參與7項百悦澤®臨牀試驗的847例患者的彙總安全性資料也被包含在該項sNDA中。

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