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首页> 外文期刊>The oncologist >EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes
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EMA Review of Daunorubicin and Cytarabine Encapsulated in Liposomes (Vyxeos, CPX-351) for the Treatment of Adults with Newly Diagnosed, Therapy-Related Acute Myeloid Leukemia or Acute Myeloid Leukemia with Myelodysplasia-Related Changes

机译：EMA审查Daunorubi蛋白和脂质体（Vyxeos，CPX-351）中的血糖素用于治疗具有新诊断的治疗相关的急性髓性白血病或急性髓性白血病的成人治疗与髓细胞平拔相关性有关的变化

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摘要

On June 28, 2018, the Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vyxeos, intended for the treatment of acute myeloid leukemia (AML). Vyxeos was designated as an orphan medicinal product on January 11, 2012. The applicant for this medicinal product was Jazz Pharmaceuticals Ireland Limited. Vyxeos is a liposomal formulation of a fixed combination of daunorubicin and cytarabine, antineoplastic agents that inhibit topoisomerase II activity and also cause DNA damage. The strength of Vyxeos is 5 units/mL, where 1 unit equals 1.0 mg cytarabine plus 0.44 mg daunorubicin. The marketing authorization holder Jazz Pharmaceuticals had found that this was an optimal ratio for the efficacy of the product. Study CLTR0310-301, a phase III, multicenter, randomized, trial of Vyxeos (daunorubicin-cytarabine) liposome injection versus standard 3+7 daunorubicin and cytarabine in patients aged 60-75 years with untreated high-risk (secondary) AML, showed a statistically significant difference between the two groups in overall survival (OS) with a median OS of 9.56 months in the daunorubicin-cytarabine arm compared with 5.95 months for standard chemotherapy (hazard ratio, 0.69; 95% confidence interval, 0.52-0.90; one-sided p = .003). The most common side effects were hypersensitivity including rash, febrile neutropenia, edema, diarrhea/colitis, mucositis, fatigue, musculoskeletal pain, abdominal pain, decreased appetite, cough, headache, chills, arrhythmia, pyrexia, sleep disorders, and hypotension.
机译：2018年6月28日，用于人类使用的药品委员会采用了积极的意见，建议授予药品VYXEOS的营销授权，用于治疗急性髓性白血病（AML）。 Vyxeos于2012年1月11日被指定为孤儿药品。此药品的申请人是Jazz Pharmaceuticals Ireland Limited。 VYXEOS是一种脂质体制剂的Daunorubi蛋白和溶血剂的固定组合，抗肿瘤剂抑制拓扑异构酶II活性，并导致DNA损伤。 Vyxeos的强度为5个单位/ ml，其中1个单位等于1.0mg Cytarabine加0.44mg Daunorubicin。营销授权持有人Jazz Pharmaceuticals发现这是产品疗效的最佳比率。研究CLTR0310-301，III期，多中心，随机试验，VYXEOS（Daunorubicin-Cytarabine）脂质体注射与标准3 + 7患者在60-75岁以上的患者，未经治疗的高风险（中学）AML，表明了一个整体存活（OS）中的两组与大生霉素 - 枯草林豆胺中的中位OS中的两组之间的统计学意义与标准化疗的5.95个月（危险比，0.69; 95％置信区间，0.52-0.90;一个 - 侧面p = .003）。最常见的副作用是过敏症，包括皮疹，发热中性粒细胞病，水肿，腹泻/结肠炎，粘膜炎，疲劳，肌肉骨骼疼痛，腹痛，减少食欲，咳嗽，头痛，寒冷，心律失常，Pyrexia，睡眠障碍和低血压。

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