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Published in: Drugs 6/2013

01-05-2013 | R&D Insight Report

Pomalidomide: First Global Approval

Authors: Shelley Elkinson, Paul L. McCormack

Published in: Drugs | Issue 6/2013

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Abstract

Pomalidomide (Pomalyst®) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom’s macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.
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Metadata
Title
Pomalidomide: First Global Approval
Authors
Shelley Elkinson
Paul L. McCormack
Publication date
01-05-2013
Publisher
Springer International Publishing AG
Published in
Drugs / Issue 6/2013
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-013-0047-x

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