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Published in: Drugs 16/2014

01-10-2014 | R&D Insight Report

Pembrolizumab: First Global Approval

Author: Raewyn M. Poole

Published in: Drugs | Issue 16/2014

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Abstract

Pembrolizumab [Keytruda® (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.
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Metadata
Title
Pembrolizumab: First Global Approval
Author
Raewyn M. Poole
Publication date
01-10-2014
Publisher
Springer International Publishing
Published in
Drugs / Issue 16/2014
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0314-5

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