Management of adverse events associated with idelalisib treatment: expert panel opinion

Abstract

Idelalisib is a first-in-class selective, oral, phosphatidylinositol 3-kinase delta (PI3Kδ) 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.

Keywords::

• Idelalisib
• phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor
• diarrhea
• colitis
• transaminitis
• pneumonitis

Acknowledgements

Gilead Sciences, Inc. sponsored this research, funded article processing charges and provided funding for professional medical writing and editorial support by Jessica Holzhauer, DVM, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company.

Potential conflict of interest:

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