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百濟神州(06160.HK):FDA受理百悅澤新適應症上市申請 獲授優先審評
阿思達克 05-20 12:01
百濟神州(06160.HK)公布,美國食品藥品監督管理局(FDA)已受理「百悅澤」(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,並授予其優先審評資格,處方藥申報者付費法案日期為2021年9月19日。

百濟神州血液學首席醫學官黃蔚娟表示,此為公司針對邊緣區淋巴瘤提交的首項藥政申請,未來幾個月中不斷與FDA進行溝通,繼續推進針對百悅澤的全球臨床開發項目。

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