和黃醫藥(00013.HK)宣佈達唯珂®(他澤司他)獲中國國家藥監局附條件批准用於治療復發或難治性濾泡性淋巴瘤
格隆匯3月21日丨和黃醫藥(00013.HK)公吿,達唯珂®(TAZVERIK®,他澤司他/tazemetostat)的新藥上市申請在中國獲附條件批准,用於治療既往接受過至少兩種系統性治療後的EZH2突變陽性復發或難治性濾泡性淋巴瘤(FL)成人患者。該批准是通過中國國家藥品監督管理局("國家藥監局")的優先審評程序取得,亦標誌着達唯珂在中國取得的首個全國性監管批准。
此次國家藥監局的附條件批准是基於一項在中國開展的多中心、開放標籤的II期橋接研究,以及益普生(Ipsen)旗下公司Epizyme,Inc.("Epizyme")在中國以外地區開展的臨牀研究。橋接研究的主要目標是評估達唯珂用於治療伴有EZH2突變的復發/難治性濾泡性淋巴瘤患者的客觀緩解率("ORR"),次要目標包括評估達唯珂用於治療伴有或不伴有EZH2突變的復發/難治性濾泡性淋巴瘤患者的緩解持續時間("DoR")、無進展生存期(PFS)、總生存期(OS)、安全性和藥代動力學。該項研究的其他詳情可登錄clinicaltrials.gov,檢索註冊號NCT05467943查看。
橋接研究的主要研究者、復旦大學附屬腫瘤醫院曹軍寧醫生表示:"此項批准為這一充滿挑戰的疾病帶來重要的治療進展。大部分濾泡性淋巴瘤患者在一生中可能經歷多次疾病復發,給治療帶來巨大的困難,並且常常導致治療結果不佳。在臨牀試驗中,達唯珂®在伴有EZH2突變患者中表現出良好的療效。公司期待將這種突破性的表觀遺傳療法帶給長久以來一直在尋求新的有效療法的中國患者。"
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