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雷莫芦单抗:全球首次获批。

Ramucirumab: first global approval.

机构信息

Adis, Auckland, New Zealand.

出版信息

Drugs. 2014 Jun;74(9):1047-58. doi: 10.1007/s40265-014-0244-2.

Abstract

Ramucirumab (Cyramza™ [US]), a fully human immunoglobulin G1 (IgG1) monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2), has been developed by Eli Lilly (formerly ImClone Systems) for the treatment of cancer. Ramucirumab has received its first global approval in the US for use as monotherapy in the treatment of advanced or metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in patients who experience disease progression on or after fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is the first treatment to be approved by the US FDA for this setting. This article summarizes the milestones in the development of ramucirumab leading to this first approval for the treatment of gastric cancer and gastro-oesophageal junction adenocarcinoma.

摘要

雷莫芦单抗(CyramzaTM [美国])是一种完全人源化 IgG1 单克隆抗体,可抑制血管内皮生长因子受体-2(VEGFR-2),由礼来(前身为 ImClone Systems)开发用于癌症治疗。雷莫芦单抗已在美国获得首次全球批准,可作为单药治疗在氟嘧啶或含铂化疗后疾病进展的晚期或转移性胃癌或胃食管结合部腺癌患者。雷莫芦单抗是美国食品和药物管理局(FDA)批准用于该治疗领域的首款药物。本文总结了雷莫芦单抗的开发历程中的重要里程碑,最终使其获得批准用于胃癌和胃食管结合部腺癌的治疗。

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