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百濟神州(06160.HK)宣佈百悦澤®(澤布替尼)治療慢性淋巴細胞白血病的新適應症上市許可申請已在中國受理並獲得突破性療法認定
格隆匯 01-28 20:38

格隆匯1月28日丨百濟神州(06160.HK)於2022年1月28日宣佈,國家藥品監督管理局(NMPA)藥品審評中心(CDE)已受理百濟神州BTK抑制劑百悦澤®(澤布替尼)用於治療成人慢性淋巴細胞白血病(CLL)或小淋巴細胞淋巴瘤(SLL)患者的新適應症上市許可申請(sNDA),並授予百悦澤®突破性療法認定(BTD)。

百濟神州血液學首席醫學官黃蔚娟醫學博士表示:「這是百悦澤®首個用於治療初治性CLL上市許可申請,此次申請基於全球3期SEQUOIA試驗的積極結果,這也是百悦澤®全球註冊計劃向前邁近的一大步。正如百濟神州在美國血液學會(ASH)上公佈的資料,在SEQUOIA試驗中,百悦澤®顯著延長了無進展生存期(PFS),並在患者中總體耐受性良好,相比於化學免疫治療展現了優效性。通過此次申請以及近期對初治性華氏巨球蛋白血癥的sNDA的遞交,我們希望拓展這一款潛在的"同類最佳"BTK抑制劑的臨牀應用範圍,使得其在中國治療血液腫瘤的應用可從復發╱難治擴大至一線治療。"

這項隨機、多中心、全球3期的SEQUOIA試驗(NCT03336333)在初治性CLL患者中,對百悦澤®與苯達莫司汀聯合利妥昔單抗(B+R)方案進行了對比,其研究結果支持了本次sNDA的申報。

該研究顯示,基於獨立審查委員會(IRC)評估,百悦澤®在PFS方面展現了對比B+R方案的優效性。中位隨訪26.15個月時,百悦澤®組的24個月PFS為85.5%(95%CI:80.1,89.6),B+R組為69.5%(95%CI:62.4,75.5),風險比(HR)為0.42(95%CI:0.27,0.63),p<0.0001。百悦澤®在患者中總體耐受性良好,安全性特徵與其在廣泛的臨牀項目中的表現一致,包括房顫的發生率較低。

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