百濟神州(688235.SH):百悦澤®(澤布替尼膠囊)新適應症上市許可申請獲受理並獲突破性治療品種認定
格隆匯1月28日丨百濟神州(688235.SH)公佈,公司近日收到國家藥品監督管理局簽發的《受理通知書》,百悦澤®(澤布替尼膠囊)用於治療成人慢性淋巴細胞白血病/小淋巴細胞淋巴瘤患者的新適應症上市許可申請獲得受理,並獲得突破性治療品種認定。
百悦澤®是一款由公司自主研發的布魯頓氏酪氨酸激酶(BTK)小分子抑制劑,目前正在全球進行廣泛的臨牀試驗項目,作為單藥和與其他療法進行聯合用藥治療多種B細胞惡性腫瘤。由於新的BTK會在人體內不斷合成,百悦澤®的設計通過優化生物利用度、半衰期和選擇性,實現對BTK蛋白完全、持續的抑制。憑藉與其他獲批BTK抑制劑存在差異化的藥代動力學,百悦澤®能在多個疾病相關組織中抑制惡性B細胞增殖。
本次百悦澤®用於治療成人慢性淋巴細胞白血病(CLL)/小淋巴細胞淋巴瘤(SLL)患者的新適應症上市許可申請是基於SEQUOIA試驗結果。SEQUOIA是一項隨機、多中心的全球3期臨牀試驗(NCT03336333),該試驗在初治性CLL/SLL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新適應症上市許可申請的申報。
基於獨立審查委員會評估,百悦澤®在無進展生存期(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%置信區間:80.1,89.6),B+R組為69.5%(95%置信區間:62.4,75.5),風險比(HR)為0.42(95%置信區間:0.27,0.63),p值小於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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