阿斯利康(AZN.US)治療膽道癌患Imfinzi在美國獲得優先審查地位
格隆匯5月4日 | 阿斯利康(AZN.US)週三説,美國FDA已批准其Imfinzi藥物和化療聯合治療局部晚期或轉移性膽道癌患者的優先審查地位。公司表示,其補充生物製劑許可證申請,或sBLA,遵循了安慰劑對照3期試驗的中期結果,該試驗顯示,與單獨標準化療相比,聯合治療的總體生存率有所提高美國FDA授予藥物應用優先審查地位,如果獲得批准,將大大改善現有的選擇。該公司表示,三期試驗的數據顯示,與標準化療相比,聯合治療降低了20%的死亡風險,估計四分之一接受治療的患者在2年後仍存活,而單獨使用化療的患者為十分之一。該公司説,數據還顯示,該組合在統計學上顯著降低了疾病進展或死亡的風險25%,而且一般耐受性良好。阿斯利康腫瘤研究與開發執行副總裁Susan Galbraith説:“我們正與FDA密切合作,為這種災難性癌症的患者帶來首個基於免疫療法的選擇,並可能為Imfinzi加上化療制定新的護理標準。”
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