百濟神州(06160.HK)：百悦澤®(澤布替尼)獲批用於治療套細胞淋巴瘤
格隆匯10月11日丨百濟神州(06160.HK)發佈公吿，百濟神州於2021年10月10日(美國東部時間)宣佈，百悦澤®(澤布替尼)已在澳大利亞獲批用於治療既往接受過至少一種療法的套細胞淋巴瘤(MCL)成人患者。2021年10月7日，百悦澤®在澳大利亞獲得首次批准，用於治療既往接受過至少一種療法的華世巨球蛋白血癥(WM)成人患者，或作為一線療法用於治療不適合化學免疫治療的患者。
在百悦澤®的兩項適應症獲得澳大利亞藥品管理局(TGA)批准後，澳大利亞患者可通過百濟神州贊助的“上市批准後╱醫保準入前藥物使用計劃”立即獲得百悦澤®。
莫納什大學臨牀血液學主任、澤布替尼臨牀項目主要研究者Stephen Opat教授表示：“套細胞淋巴瘤(MCL)是一種不常見的非霍奇金淋巴瘤(NHL)，通常被認為是一種不可治癒的疾病。雖然大多數患者在初次接受治療時能產生良好的緩解，但事實上，隨着時間推移，所有患者的淋巴瘤都會出現疾病進展。對於復發或難治性MCL，現有療法往往無法取得理想療效，或可能因副作用導致治療終止。澤布替尼作為一款具有高選擇性的BTK抑制劑，在兩項治療復發難治性MCL的臨牀試驗中取得了積極的結果，我很欣喜地看到百悦澤®將為澳大利亞患者帶來一項全新的治療選擇。”
“澳大利亞是世界上NHL發病率最高的國家之一，許多患者亟需新的治療選擇，以替代現有療法，”澳大利亞淋巴瘤協會首席執行官Sharon Winton表示，“對於MCL的患者而言，新療法意義重大，尤其對於那些在疾病晚期確診、難以耐受較為激進的療法的患者而言。我相信，這些患者也將期待這一新療法的到來。”
百濟神州已向澳大利亞藥品福利諮詢委員會(PBAC)提交了百悦澤®的報銷申請，其中MCL適應症已於2021年7月被推薦納入報銷補貼清單。百濟神州血液學首席醫學官黃蔚娟醫學博士表示：“相比第一代BTK抑制劑，百悦澤®的設計旨在提供深度且持久的緩解，同時減少脱靶效應帶來的不良反應。百悦澤®早期臨牀試驗是在澳大利亞啟動，繼百悦澤®用於治療WM的適應症獲批，我們很高興又能為更多需要新治療選擇的澳大利亞患者提供這一療法。”
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