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Drugs
Published in: Drugs 14/2014

01-09-2014 | R&D Insight Report

Idelalisib: First Global Approval

Author: Anthony Markham

Published in: Drugs | Issue 14/2014

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Abstract

Idelalisib (Zydelig®) is a highly specific small-molecule phosphatidylinositol-3-kinase (PI3Kδ) inhibitor that has been developed as an oral treatment for B cell haematological cancers. It has received its first approval in the US in July 2014 for the treatment of relapsed chronic lymphocytic leukaemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (NHL) and relapsed small lymphocytic leukaemia (SLL). Idelalisib is under regulatory review in the EU—where it has received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use—and in clinical development for CLL in Australia and Canada. This article summarizes the milestones in the development of Idelalisib leading to this first approval for relapsed CLL, NHL and SLL.
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Metadata
Title
Idelalisib: First Global Approval
Author
Anthony Markham
Publication date
01-09-2014
Publisher
Springer International Publishing
Published in
Drugs / Issue 14/2014
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0285-6

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