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              2014年12月FDA批準新藥奧拉帕尼olaparib
              2014-12-31 10:04:29 來源:有機化學網 瀏覽:9170

              2014年12月21日,盡管遭到FDA專家委員拒絕,但FDA還是毫不猶豫的加速批準了阿斯利康的卵巢癌藥物Lynparza(olaparib)。該藥的獲批,也標志著阿斯利康管線中新增了一枚重磅產品。就在前一天,Lynparza也獲得了歐盟的批準。

              具體而言,FDA已批準Lynparza用于既往經至少3次化療治療失敗的BRCA胚系突變晚期卵巢癌患者的治療。Lynparza(olaparib)是一種首創口服多聚ADP核糖聚合酶(PARP)抑制劑,利用DNA修復途徑的缺陷,優先殺死癌細胞。目前,阿斯利康正開展多個III期研究,調查olaparib用于BRCA突變卵巢癌、胃癌、乳腺癌的治療。

              Lynparza通過FDA的加速審批程序批準,該藥的獲批是基于一項單組開放標簽II期研究的數據及其他研究的安全性數據。該II期研究在137例既往經至少3次化療失敗的BRAC胚系突變晚期卵巢癌患者中開展,數據表明,olaparib維持療法取得了34%的總緩解率(ORR),中位緩解持續時間為7.9個月。此前的一項研究表明,與安慰劑相比,olaparib顯著延長了無進展生存期(PFS:11.2個月 vs 4.3個月,p<0.00001)。

              今年2月,阿斯利康根據一項II期臨床數據向FDA提交了olaparib的監管文件,該研究評估了olaparib治療鉑類敏感性復發性高度漿液性卵巢癌的治療。今年6月,FDA腫瘤藥物顧問委員會(ODAC)以11:2的投票結果拒絕加速批準olaparib,并建議FDA等待阿斯利康正在開展的III期臨床研究結果。今年7月,應FDA要求,阿斯利康提交了一份關于olaparib新藥申請的重大修訂,提供了額外數據支持了olaparib用于既往經至少3次化療治療失敗的BRCA胚系突變卵巢癌患者的治療。

              目前,阿斯利康正在開展III期SOLO臨床項目,FDA將對該項目的2個III期研究SOLO-2和SOLO-3進行全面審查,屆時再決定是否將olaparib加速批準轉為完全批準。SOLO-2研究正在調查olaparib作為一種維持療法相對于安慰劑的療效;SOLO-3研究正在調查治療復發性卵巢癌時olaparib相對于標準化療的療效。SOLO-2研究的數據預計將在2015年獲得,SOLO-3研究數據預計將在2019年獲得。

              今年早些時候,在拒絕輝瑞1140億美元收購時,阿斯利康向投資者描繪了其腫瘤學管線的美好前景。阿斯利康對olaparib寄予厚望,認為該藥的年銷售額將突破20億美元。不過,阿斯利康對腫瘤免疫療法PD-L1抑制劑MEDI4736和另一種抗癌藥AZD9291的期望更高,預測2者的年銷售峰值分別為65億美元和30億美元,后者目前正處于I期臨床。然而,這些產品要想實現預期目標,將取決于在一系列癌癥中的臨床成功。

              另外,卵巢癌領域,FDA今年11月批準羅氏安維汀(Avastin)用于復發性卵巢癌。生物技術巨頭安進研發的一款卵巢癌藥物AMG-386已處于III期階段。

              基本信息
              英文名 Olaparib
              別名 1-(Cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1-phthalazinyl)methyl]-2-fluorobenzoyl]piperazine
              產品名稱 奧拉帕尼; 1-(環丙甲酰基)-4-[5-[(3,4-二氫-4-氧代-1-酞嗪基)甲基]-2-氟苯甲酰]哌嗪
              copyRight
              分子結構 CAS 登錄號:763113-22-0 (937799-91-2), 奧拉帕尼, 1-(環丙甲酰基)-4-[5-[(3,4-二氫-4-氧代-1-酞嗪基)甲基]-2-氟苯甲酰]哌嗪
              分子式 C24H23FN4O3
              分子量 434.46
              CAS 登錄號 763113-22-0 (937799-91-2)
               
              物理化學性質
              密度 1.43

               

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