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              2018年11月FDA批準上市新藥gilteritinib
              2018-11-30 10:02:48 來源:有機化學網 瀏覽:5052
              2018年11月28日,FDA批準新藥gilteritinib用于治療成人急性白血病,有望對近三成的急性髓細胞白血病患者產生療效。

              這款藥物名為XOSPATA,獲批用于治療FLT3基因突變引發的復發性或難治性急性髓細胞白血病。約25%到30%的急性髓細胞白血病患者存在這種基因突變。

              美藥管局藥品評價和研究中心血液病與腫瘤產品辦公室代理主任理查德·帕茲杜爾說,新藥以FLT3基因為靶點,是第一種獲批能單獨用來治療該基因突變引發的復發性或難治性急性髓細胞白血病的藥物。

              急性髓細胞白血病是成年人常見的急性白血病。美藥管局說,針對138名FLT3基因突變引發的復發性或難治性急性髓細胞白血病患者的臨床試驗顯示,21%的患者完全緩解(無疾病證據且血細胞計數完全恢復)或血液學部分恢復(無疾病證據但血細胞計數部分恢復)。在試驗之初接受了紅細胞或血小板輸注的106名患者中,31%的患者至少56天內無須再次輸血。

               

              CAS No.: 1254053-43-4
              Formula: C29H44N8O3
              Exact Mass: 552.35400
              Molecular Weight: 552.71100

               

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