• Steven E Coutré, Jacqueline C Barrientos, Jennifer R Brown, Sven de Vos, Richard R Furman, Michael J Keating, Daniel Li, Susan M O'Brien, John M Pagel, Martin H Poleski, Jeff P Sharman, Nai-Shun Yao, and Andrew D Zelenetz.
• a Stanford Cancer Institute, Stanford University School of Medicine , Stanford , CA , USA.
• Leuk. Lymphoma. 2015 Jan 1; 56 (10): 2779-86.

AbstractIdelalisib 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.

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