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百濟神州(688235.SH):FDA批准百悦澤®(澤布替尼膠囊)用於治療慢性淋巴細胞白血病或小淋巴細胞淋巴瘤成人患者

格隆匯1月20日丨百濟神州(688235.SH)公佈,公司近日獲悉,美國食品藥品監督管理局(FDA)已批准其布魯頓氏酪氨酸激酶(BTK)抑制劑百悦澤®(澤布替尼膠囊)用於治療慢性淋巴細胞白血病(CLL)或小淋巴細胞淋巴瘤(SLL)成人患者。

此次在美國的獲批基於兩項全球3期臨牀試驗,這兩項試驗證明了百悦澤®在CLL患者中的優效性及其良好的安全性特徵。此次獲批使得百悦澤®為CLL/SLL患者帶來新的治療選擇,有助於進一步提升該藥物的可及性。

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