百濟神州(06160.HK)：美國FDA批准百悦澤®用於治療華氏巨球蛋白血癥患者
格隆匯9月2日丨百濟神州(06160.HK)發佈公吿，2021年9月2日，百濟神州今日宣佈百悦澤® (BRUKINSA®，澤布替尼)獲得美國食品藥品監督管理局(FDA)批准用於治療成年華氏巨球蛋白血癥(WM)患者。
百濟神州血液學首席醫學官黃蔚娟博士表示：“我們十分高興FDA今天批准了百悦澤®在美國的第二項適應症。此次獲批使得百悦澤®能夠為華氏巨球蛋白血癥患者帶來一種安全、有效的治療新選擇。正如我們從ASPEN試驗中所看到的，百悦澤®能夠提升這些患者的治療效果，改善他們的生活。”
黃蔚娟博士繼續評論道：“不到兩年的時間，百悦澤®在已在全球範圍取得11項監管機構的批准，其中包括2項在美國的批准，這表明百悦澤®正逐漸成為針對B細胞惡性腫瘤的一項卓有成效的治療選擇，並拓展其全球足跡，將有望惠及更多患者。我們將繼續通過廣泛的臨牀開發項目對百悦澤®進行評估，以獲取更多臨牀證據，進一步確立其潛在的“同類最優”地位。”
美國丹娜法博癌症研究院(Dana-Farber Cancer Institute)華氏巨球蛋白血癥研究 Bing中心主任、哈佛醫學院醫學教授Steven Treon博士評論道：“ASPEN試驗充分表明，百悦澤®是用於治療華氏巨球蛋白血癥患者的一款具有高度活性的抑制劑，相較第一代BTK抑制劑，在一系列具有臨牀重要性的副作用中顯示出了更佳的耐受性。百悦澤®獲批能為華氏巨球蛋白血癥患者帶來一款全新的重要靶向治療選擇。”
國際華氏巨球蛋白血癥基金會(IWMF)主席Pete DeNardis表示：“百悦澤®獲批用於治療華氏巨球蛋白血癥，為這種罕見類型的淋巴瘤帶來了第二款獲批的治療藥物，對患者來説是一個福音，這意味着華氏巨球蛋白血癥患者有了更多治療選擇，特別是百悦澤®這類藥物可通過口服給藥、採用單藥治療，從而能夠改善患者的治療體驗。”
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