FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy
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DOI：
10.1158/1078-0432.ccr-15-0887
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发表时间：
2015-10-01
影响因子：
11.5
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Kim, Geoffrey;Ison, Gwynn;Pazdur, Richard
2014年12月19日，FDA批准奥拉帕尼胶囊（Lynparza; AstraZeneca）用于治疗已接受三线或三线以上化疗的有害或疑似有害生殖系BRCA突变（gBRCAm）晚期卵巢癌患者。BRACAnalysis CDx（Myriad Genetic Laboratories，Inc.）同时获得批准。一项国际多中心、单组试验入组了137例既往接受过三线或三线以上化疗的可测量gBRCAm相关卵巢癌患者。患者口服奥拉帕尼400 mg，每日两次，直至疾病进展或出现不可接受的毒性。客观缓解率（ORR）为34%，中位缓解持续时间为7.9个月。奥拉帕尼治疗患者中最常见的不良反应（>= 20%）为贫血、恶心、疲劳（包括虚弱）、呕吐、腹泻、味觉障碍、消化不良、头痛、食欲下降、鼻咽炎/咽炎/上呼吸道感染、咳嗽、关节痛/肌肉骨骼疼痛、肌痛、背痛、皮炎/皮疹和腹痛/不适。本试验入组的患者中有2%发生骨髓增生异常综合征和/或急性髓性白血病。(C)2015年AACR。
On December 19, 2014, the FDA approved olaparib capsules (Lynparza; AstraZeneca) for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. The BRACAnalysis CDx (Myriad Genetic Laboratories, Inc.) was approved concurrently. An international multicenter, single-arm trial enrolled 137 patients with measurable gBRCAm-associated ovarian cancer treated with three or more prior lines of chemotherapy. Patients received olaparib at a dose of 400 mg by mouth twice daily until disease progression or unacceptable toxicity. The objective response rate (ORR) was 34% with median response duration of 7.9 months in this cohort. The most common adverse reactions (>= 20%) in patients treated with olaparib were anemia, nausea, fatigue (including asthenia), vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis/pharyngitis/upper respiratory infection, cough, arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash, and abdominal pain/discomfort. Myelodysplatic syndrome and/or acute myeloid leukemia occurred in 2% of the patients enrolled on this trial. (C) 2015 AACR.