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百濟神州(06160.HK):百悦澤(澤布替尼)獲歐洲藥品管理局人用藥品委員會積極意見,支持其用於治療慢性淋巴細胞白血病成人患者

格隆匯10月14日丨百濟神州(06160.HK)公佈,歐洲藥品管理局(EMA)人用藥品委員會(CHMP)已發佈其推薦百悦澤(澤布替尼)獲得上市許可的積極意見,建議批准百悦澤用於治療慢性淋巴細胞白血病(CLL)成人患者。

“百悦澤經特殊設計以改善第一代布魯頓氏酪氨酸激酶抑制劑(BTKi)在有效性和安全性方面的侷限。正因如此,通過在復發╱難治性慢性淋巴細胞白血病(R/RCLL)中開展的最大規模的頭對頭比較不同BTK抑制劑的研究,百悦澤成為唯一與伊布替尼對比呈優效性的BTK抑制劑;此外,無論患者的年齡、合併症、突變狀態或風險狀態如何,百悦澤在初治(TN)患者中較苯達莫司汀聯合利妥昔單抗(BR)表現出無進展生存期(PFS)的優效性

百濟神州血液學首席醫學官MehrdadMobasher醫學博士及公共衞生碩士表示:“本次積極意見印證了百濟神州正聚焦並積極履行公司使命,在全球加快創新藥物開發、擴大藥物可及性

本次CHMP的推薦基於兩項全球3期頭對頭臨牀試驗中百悦澤所展現的優效性。這兩項試驗為在復發╱難治性(R/R)慢性淋巴細胞白血病(CLL)患者中開展的百悦澤對比伊布替尼的ALPINE(NCT03734016)研究和在既往未經治療的CLL患者中開展的百悦澤對比苯達莫司汀聯合利妥昔單抗(BR)的SEQUOIA(NCT03336333)研究。這兩項研究招募的患者來自17個國家,包括美國、中國、澳大利亞、紐西蘭以及歐洲地區的一些國家。

德國慕尼克大學學術教學醫院慕尼克診所血液腫瘤學負責人Clemens Wendtner教授表示:“BTK抑制劑已被證明是治療CLL的高效口服療法;然而,不良事件所導致的負擔以及治療終止給患者的預後帶來了負面影響。百悦澤用於治療CLL的兩項大型頭對頭3期試驗的結果證明,在治療相關的房顫╱房撲和治療終止的發生方面百悦澤呈現一致性的、更低的發生率,且在各線治療中均展現出有效性。這些臨牀試驗數據表明,百悦澤有望成為CLL領域變革型的治療選擇

百濟神州高級副總裁、歐洲地區負責人Gerwin Winter表示:“我們為過去一年將百悦澤引入歐洲的血液腫瘤治療領域所取得的快速進展感到自豪。基於此次積極意見,我們期待這一重要藥物惠及更多歐盟地區的血液腫瘤患者

在CHMP給出積極意見之後,歐盟委員會將審議百濟神州提出的上市申請,並預計在67天內做出最終審評決議。該決議將適用於歐盟全部27個成員國以及冰島和挪威。

百悦澤目前已在歐盟獲批用於治療既往接受過至少一種治療的華氏巨球蛋白血癥(WM)成人患者,或作為不適合接受免疫化療患者的一線治療。上個月,CHMP發佈了積極意見,建議批准百悦澤用於治療既往接受過至少一種抗CD20療法的邊緣區淋巴瘤(MZL)成人患者。

在歐洲,百濟神州目前已在奧地利、比利時、丹麥、英格蘭和威爾士、德國、愛爾蘭、義大利、西班牙和瑞士獲得了百悦澤治療華氏巨球蛋白血癥(WM)的報銷,其他歐盟國家也正在推進將該藥物納入其報銷體系的進程中。

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