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Erschienen in: Drugs 8/2017

01.05.2017 | AdisInsight Report

Avelumab: First Global Approval

verfasst von: Esther S. Kim

Erschienen in: Drugs | Ausgabe 8/2017

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Abstract

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.
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Metadaten
Titel
Avelumab: First Global Approval
verfasst von
Esther S. Kim
Publikationsdatum
01.05.2017
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 8/2017
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-017-0749-6

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