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Belinostat: First Global Approval

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Abstract

Belinostat [Beleodaq® (US)], a small-molecule hydroxamate-type inhibitor of class I, II and IV histone deacetylase (HDAC) enzymes, has been developed by TopoTarget and Spectrum Pharmaceuticals for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Belinostat has received its first global approval as monotherapy for this indication in the US, under the Food and Drug Administration’s accelerated approval program. This article summarizes the milestones in the development of belinostat leading to this first approval for the treatment of PTCL.

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Disclosure

The preparation of this report was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. R.M. Poole is a contracted employee of Adis, Springer SBM.

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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. Belinostat: First Global Approval. Drugs 74, 1543–1554 (2014). https://doi.org/10.1007/s40265-014-0275-8

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