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              2018年11月FDA批準上市新藥glasdegib
              2018-11-22 08:46:08 來源:有機化學網 瀏覽:4654
              2018年11月21日,FDA批準Daurismo (glasdegib) 用于治療新診斷的年齡≥75歲或者由于存在共病而不能接受高強度化療的急性髓性白血病(AML)患者。

              glasdegib是一種新型口服Smoothened蛋白(SMO)抑制劑,聯合低劑量阿糖胞苷(LDAC)用于治療AML。

              AML是成人中最常見的惡性白血病,在所有白血病類型中生存率最低。根據美國國家癌癥研究所(NCI)統計,在2018年大約19520名患者被診斷患有AML,大約10670名患者因此去世。治療AML的標準療法為高強度化療。不過幾乎有半數確診為AML的成人患者由于合并癥以及化療相關毒性而不能接受標準的高強度化療。

              glasdegib的安全性和有效性評估主要來自一項涉及111名新診斷AML患者的臨床試驗,患者隨機分配接受glasdegib聯合LDAC或單獨LDAC治療。結果顯示,接受glasdegib聯合LDAC治療的患者的中位總生存期為8.3個月,而接受單獨LDAC治療的患者的中位總生存期為4.3個月,兩組患者的總體生存期相差4個月,統計學意義顯著。

              FDA報告的glasdegib的常見不良反應包括貧血,疲勞,出血,發熱性中性粒細胞減少,肌肉疼痛,惡心,水腫,血小板減少,呼吸困難,食欲下降,消化不良,粘膜炎,便秘和皮疹。臨床應用該藥時,應監測患者的心臟電活動變化(例如,QT延長)。

              glasdegib已被FDA授予優先審查資格并獲得“孤兒藥”認定。

              CAS No.: 1095173-27-5
              Formula: C21H22N6O
              Exact Mass: 374.18600
              Molecular Weight: 374.43900

               

               

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