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Drugs

, Volume 74, Issue 14, pp 1701–1707 | Cite as

Idelalisib: First Global Approval

  • Anthony MarkhamEmail author
R&D Insight Report

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.

Keywords

Chronic Lymphocytic Leukaemia Follicular Lymphoma Hodgkin Lymphoma Mantle Cell Lymphoma Bendamustine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

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. A. Markham is a contracted employee of Adis, Springer SBM.

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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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