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Review Article

pegfilgrastimapgf (Nyvepria): USFDA批准用于治疗化疗引起的发热性中性粒细胞减少症的生物仿制药及临床试验最新进展

卷 23, 期 9, 2022

发表于: 13 May, 2022

页: [924 - 932] 页: 9

弟呕挨: 10.2174/1389450123666220408101152

价格: $65

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摘要

Pegfilgrastim-apgf (nyvepria) 目前已被 FDA 批准用于治疗与接受骨髓抑制性抗癌药物的非髓系恶性肿瘤相关的发热性中性粒细胞减少症。 它是由美国辉瑞公司开发的，是一种聚乙二醇化白细胞生长刺激因子，可降低接受抗癌药物治疗的患者发热性中性粒细胞减少症的发生率。 Nyvepria 是 pegfilgrastim 的生物仿制药，于 2020 年 6 月 10 日获得 FDA 批准。它是 FDA 批准的第四个治疗发热性中性粒细胞减少症感染的药物。 本综述将 nyvepria 开发中的指标简化为批准治疗发热性中性粒细胞减少症 (FN)、生物仿制药监管框架以及临床试验 (CT) 的最新更新。

关键词: Pegfilgrastim-apgf (Nyvepria)，生物类似药，发热性中性粒细胞减少症，非髓细胞癌，FDA，抗癌药物。

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