迪哲醫藥(688192.SH):DZD8586獲美國FDA快速通道認定
格隆匯8月6日丨迪哲醫藥(688192.SH)公佈,公司在研產品DZD8586獲美國食品藥品監督管理局(以下簡稱“FDA”)授予“快速通道認定”(“FastTrack
Designation”)用於既往接受過至少兩線治療(包括布魯頓氏酪氨酸激酶(BTK)抑制劑和 BCL-2
抑制劑)的復發難治性慢性淋巴細胞白血病/小淋巴細胞淋巴瘤(CLL/SLL)。
DZD8586
是公司自主研發的全球首創 LYN/BTK 雙靶點抑制劑,可同時阻斷 BTK 依賴性和非依賴性 BCR
信號通路,抑制降解劑的耐藥突變,對TEC家族其他成員具有高選擇性,且可完全穿透血腦屏障。此次被FDA 授予“快速通道認定”,是基於 DZD8586
針對既往接受過共價或非共價BTK 抑制劑及BTK降解劑治療的 CLL/SLL 患者的 I/II
期臨牀研究彙總分析,該研究結果在今年2025美國臨牀腫瘤學會(ASCO)和第 18 屆國際惡性淋巴瘤會議(ICML)上以口頭報告的形式報告,並在 2025
歐洲血液學協會(EHA)年會上發佈。
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