阿斯利康、默克的Lynparza在歐盟獲批擴大用於前列腺癌
格隆匯12月21日丨歐盟批准阿斯利康(AZN.US)和默克(MRK.US)Lynparza聯合阿比妥龍(abiraterone)和強的松(prednisolone)治療臨牀不適應化療的轉移性去勢抵抗性前列腺癌成年男性。歐委會批准Lynparza(olaparib)是由一項名為PROpel的3期臨牀試驗數據支持的。阿斯利康腫瘤事業部執行副總裁Dave Fredrickson説:“在PROpel試驗中,與標準護理治療相比,林帕扎聯合阿比特龍已被證明可將疾病進展風險降低34%。”Lynparza已經在歐盟被批准用於治療某些類型的乳腺癌、卵巢癌、胰腺癌和前列腺癌。在Lynparza在歐盟獲得批准後,阿斯利康將從默克公司獲得1.05億美元的監管里程碑付款,預計這將在2022年第四季度被默克公司記為合作收入。該藥物組合在美國是類似用途的優先考慮對象,FDA預計將在2023年第一季度做出決定。
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