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Pembrolizumab: First Global Approval

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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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Article Open access 18 August 2015

Leila Khoja, Marcus O. Butler, … Anthony M. Joshua

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    Raewyn M. Poole

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This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

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Poole, R.M. Pembrolizumab: First Global Approval. Drugs 74, 1973–1981 (2014). https://doi.org/10.1007/s40265-014-0314-5

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