百濟神州(06160.HK):百悦澤®(澤布替尼)在澳大利亞取得首次批准用於治療華氏巨球蛋白血癥
格隆匯10月8日丨百濟神州(06160.HK)於2021年10月7日(美國東部時間)宣佈,旗下產品百悦澤®(澤布替尼)在澳大利亞獲批用於治療既往接受過至少一種療法的華氏巨球蛋白血癥(WM)成人患者,或作為一線療法以用於治療不適合化學免疫治療的患者。在百悦澤®獲得澳大利亞藥品管理局(TGA)批准之後,通過百濟神州贊助的患者援助計劃,患者可以在百悦澤®雖已獲批但尚未納入醫保的情況下即刻獲得藥品。
此外,百悦澤®近期也已獲得新加坡衞生科學局(HSA)批准,用於治療既往接受過至少一種治療的套細胞淋巴瘤(MCL)成人患者。
百悦澤®臨牀項目主要研究者、澳大利亞Peter MacCallum癌症中心低級別淋巴瘤及慢性淋巴細胞白血病疾病小組負責人Con Tam教授(內外全科醫學士、醫學博士)表示:“BTK抑制是治療WM患者的一種成熟手段,而ASPEN研究顯示,百悦澤®療效顯著,相比第一代BTK抑制劑,更優化了耐受性。百濟神州於2013年首次在澳大利亞開始百悦澤®的臨牀試驗,此後,許多澳大利亞患者入組了這些持續進行的臨牀試驗,並從治療中獲益。我們期待這項療法將為澳大利亞的WM患者帶來新的希望。”
澳大利亞WMozzies組織的負責人David Young評論道:“儘管WM是一種進展緩慢的淋巴瘤,但並非所有患者都能對現有的治療方案產生良好的響應,有許多患者由於不良反應而終止了治療。百悦澤®已經顯示出為患者改善臨牀獲益與治療結局的潛力,我們十分欣喜能夠見證澳大利亞的WM患者如今有機會立即用上這種新一代的BTK抑制劑。”
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。在這一首次申請中,百濟神州預期對WM的報銷申請將進入加速決議通道,以期確定WM被納入報銷的時間。
百濟神州血液學首席醫學官黃蔚娟醫學博士表示:“百悦澤®已被證實可觸發深度、持久的緩解效果,並減少由於脱靶帶來的不良反應,這意味着與既有的BTK抑制劑相比,它能夠帶來更佳的臨牀獲益。我們由衷感謝澳大利亞的研究者、參與臨牀試驗的患者及其家屬為TGA批准所作的貢獻。能夠為罹患WM的澳大利亞患者提供百悦澤®,標誌着我們朝着為全球患者提供可負擔的腫瘤藥物的願景又邁進一步。”
“此次百悦澤®在澳大利亞的獲批,以及近期其在新加坡的獲批,標誌着百悦澤®在亞太地區的進一步拓展。”百濟神州副總裁、亞太區商業化負責人Adam Roach補充道,“我們已經在這些市場建立了醫學和商業化團隊,以期進一步實現我們的目標,將這款潛在“同類最優”的BTK抑制劑帶給全球患者。”
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