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Drugs. 2017 May;77(8):929-937. doi: 10.1007/s40265-017-0749-6.
Avelumab (Bavencio) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.
avelumab（Bavencio）是一种静脉注射的程序性死亡配体 1 阻断人抗体，最初由 EMD Serono Inc.（德国达姆施塔特默克股份有限公司的生物制药部门）开发[现为 EMD Serono Inc. 和辉瑞共同开发和商业化]，用于治疗各种肿瘤。它已在美国获得加速批准，用于治疗成人和 12 岁及以上儿科患者的转移性 Merkel 细胞癌（mMCC）。avelumab 在治疗 mMCC 的营销授权申请正在欧盟进行监管审查，avelumab 在治疗尿路上皮癌的生物制品许可申请正在接受 FDA 的优先审查，avelumab 正在国际上各个阶段开发用于治疗各种癌症。本文总结了 avelumab 开发的里程碑，最终导致了对 mMCC 的首次批准。
