Publication Date

2015

Journal Title

Leuk Lymphoma

Abstract

Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kdelta) inhibitor approved for the treatment of several types of blood cancer. Idelalisib has demonstrated significant efficacy and a tolerable safety profile in clinical trials. However, the US prescribing information contains a black box warning for fatal and/or severe diarrhea or colitis, hepatotoxicity, pneumonitis and intestinal perforation. An expert panel was convened to review the pathology of these treatment-emergent adverse events (TEAEs) to propose key management tools for patients receiving idelalisib therapy. This article provides an overview of idelalisib TEAEs reported in clinical trials, and a summary of the panel's recommendations for identification and management of idelalisib treatment-emergent diarrhea or colitis as well as a discussion of transaminitis and pneumonitis. For idelalisib-related diarrhea or colitis (including unresolved grade 2 and grade >/= 3), after exclusion of infectious causes, the panel recommends individualized treatment with budesonide or oral or intravenous steroid therapy.

Volume Number

56

Issue Number

10

Pages

2779-86

Document Type

Article

EPub Date

2015/03/03

Status

Faculty

Facility

School of Medicine

Primary Department

Hematology/Medical Oncology

PMID

25726955

DOI

10.3109/10428194.2015.1022770


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