百濟神州(06160.HK)：百悦澤®(澤布替尼)用於初治華氏巨球蛋白血癥的新適應症上市申請在中國獲得受理
格隆匯1月20日丨百濟神州(06160.HK)公吿，於2022年1月20日宣佈，中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)已受理其BTK抑制劑百悦澤®(澤布替尼)用於治療華氏巨球蛋白血癥(WM)成人患者的新適應症上市申請(sNDA)。
百濟神州血液學首席醫學官黃蔚娟醫學表示："百悦澤繼獲批用於治療復發或難治性華氏巨球蛋白血癥(WM)患者後，此次sNDA申請也獲得NMPA受理，這對我們來説是一個好消息。這意味着一旦取得批准，更多中國的華氏巨球蛋白血癥患者將有機會用上這款藥物。ASPEN試驗表明，百悦澤®對WM患者而言是一項安全有效的治療選擇，引起房顫等心血管事件的風險更低。在ASPEN試驗數據的支援下，百悦澤®已經在美國、加拿大、澳大利亞和歐盟獲批用於WM患者的治療我們期待與CDE繼續探討，爭取將這一具備"同類最優"潛力的藥物提供給更多中國WM患者的機會。"
此次sNDA申請基於ASPEN試驗數據，這是一項隨機、開放標籤、多中心的3期臨牀試驗(NCT03053400)，對比了百悦澤®與伊布替尼用於治療復發╱難治性(R/R)或初治(TN)WM患者的數據。
經獨立審查委員會(IRC)根據第六屆華氏巨球蛋白血癥國際研討會(IWWM-6)修訂版緩解標準(Treon2015)評估，百悦澤®治療組在總體意向性治療(ITT)人羣中的完全緩解(CR)和非常好的部分緩解(VGPR)率的綜合為28%(95%CI：20,38)，而伊布替尼組為19%(95%CI：12,28)。儘管兩組資料的差異未達到統計學顯著性(p=0.09)，但百悦澤展現了更高的VGPR率數據，且緩解品質呈現出改善趨勢。在ASPEN試驗中，與伊布替尼相比，百悦澤®取得了更具優勢的安全性數據，特定不良事件的發生率較更低，包括房顫╱房撲(2%vs.15%)和大出血(6%vs.9%)。在101例接受百悦澤治療的WM患者中，4%的患者因不良事件而終止治療，14%的患者因不良事件降低用藥劑量。
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