百濟神州(06160.HK)：百悦澤®(澤布替尼)在歐盟獲批用於治療成人華氏巨球蛋白血癥
格隆匯11月24日丨百濟神州(06160.HK)發佈公吿，2021年11月24日，歐盟委員會(EC)批准百悦澤® (澤布替尼)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，或作為不適合化療免疫治療WM患者的一線治療方案。該批准適用於歐盟(EU)全部27個成員國，以及冰島和挪威。百濟神州正努力將這一新的治療選擇儘快提供給歐洲的WM患者。
“雖然BTK抑制劑已經成為針對WM的一項較為成熟的療法，但百悦澤®的獲批仍為WM患者提供了一種重要的治療新選擇，有望提升患者的治療結局。”德國烏爾姆大學醫院(University Hospital Ulm)綜合癌症中心醫學主任、ASPEN試驗的研究者之一－Christian Buske教授表示，“ASPEN試驗表明，百悦澤®有可能為患者帶來深度、持久的緩解，且耐受性顯著改善。如今，歐洲的醫生及WM患者將有望早日用上這一創新藥物。”
繼9月獲得歐洲藥品管理局(EMA)人用藥品委員會(CHMP)的積極意見之後，百悦澤®此次獲得歐盟委員會批准，是基於ASPEN試驗的結果。儘管在該試驗中，百悦澤®未能達到與深度緩解(VGPR或更好)相關的統計學優效性的主要終點，但與伊布替尼相比，百悦澤®仍展現出了臨牀獲益及安全性優勢。
百濟神州血液學首席醫學官黃蔚娟醫學博士表示：“隨着百悦澤®在歐盟獲批，我們將繼續踐行承諾，使這一具備“同類最優”潛力的BTK抑制劑在全球範圍惠及更多有望從中獲益的患者。百悦澤®的設計旨在最大化BTK靶點佔有率、最小化脱靶效應，並已在ASPEN試驗中展現了對比伊布替尼在有效性、安全性和耐受性方面的優勢。我們相信百悦澤®將有望成為WM患者及其醫生的優選治療方案。”
百濟神州高級副總裁、歐洲商業化負責人Gerwin Winter表示：“我們已經在歐洲建立了一支強大的團隊，致力於早日把百悦澤®送到有需要的WM患者手中。歐盟委員會的批准是百濟神州在歐洲地區擴展的一個重要里程碑，意味着我們朝着提升全球腫瘤創新藥物可及性的目標又邁進一步。”
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