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Idelalisib: a review of its use in chronic lymphocytic leukaemia and indolent non-Hodgkin’s lymphoma

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Abstract

Idelalisib (Zydelig®) is a first-in-class, orally administered, phosphatidylinositol 3-kinase-δ inhibitor that was recently approved for the treatment of relapsed chronic lymphocytic leukaemia (CLL), relapsed follicular B-cell non-Hodgkin’s lymphoma (NHL) and relapsed small lymphocytic lymphoma (SLL) in the USA and for the treatment of CLL and refractory follicular lymphoma in the EU. In a pivotal phase III trial in patients with relapsed CLL who were not able to receive cytotoxic agents, recipients of idelalisib plus rituximab had significantly improved progression-free survival, overall survival, overall response and lymph node response, compared with recipients of placebo plus rituximab. In a pivotal phase II trial, idelalisib monotherapy was effective in patients with relapsed indolent NHL who were refractory to rituximab and an alkylating agent, including in the subgroups of patients with follicular lymphoma or SLL. Oral idelalisib had a generally manageable adverse event profile, although episodes of serious/fatal diarrhoea or colitis, hepatotoxicity, pneumonitis and intestinal perforation were reported. In conclusion, idelalisib represents an important advance in the treatment of relapsed CLL and relapsed indolent NHL.

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Data selection sources

Relevant medical literature (including published and unpublished data) on idelalisib was identified by searching databases including MEDLINE (from 1946) and EMBASE (from 1996) [searches last updated 15 December 2014], bibliographies from published literature, clinical trial registries/databases and websites. Additional information was also requested from the company developing the drug.

Search terms

Idelalisib, Zydelig, CAL-101, GS-1101.

Study selection

Studies in patients with chronic lymphocytic leukaemia or indolent non-Hodgkin lymphoma who received idelalisib. When available, large, well-designed, comparative trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Disclosure

The preparation of this review was not supported by any external funding. Gillian Keating is a salaried employee of Adis/Springer. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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  1. Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Gillian M. Keating

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  1. Gillian M. Keating
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Correspondence to Gillian M. Keating.

Additional information

The manuscript was reviewed by: E. Bachy, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France; S. de Vos, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA; J.P. Sharman, US Oncology Research, Springfield, OR, USA; A. Viadort, Department of Internal Medicine III, University Hospital Ulm, Ulm, Germany; and P.L. Zinzani, Institute of Hematology ‘L. e A. Seràgnoli’, University of Bologna, Bologna, Italy.

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Keating, G.M. Idelalisib: a review of its use in chronic lymphocytic leukaemia and indolent non-Hodgkin’s lymphoma. Targ Oncol 10, 141–151 (2015). https://doi.org/10.1007/s11523-015-0359-8

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  • DOI: https://doi.org/10.1007/s11523-015-0359-8

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