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Review

Olutasidenib

No authors listed
In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Olutasidenib

No authors listed.
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Excerpt

Olutasidenib is a small molecule inhibitor of mutated isocitrate dehydrogenase-1 (IDH1) that is used in the treatment of adults with relapsed or refractory acute myelogenous leukemia with mutated IDH1. Olutasidenib is associated with a high rate of serum aminotransferase elevations during therapy that can be severe and require early discontinuation and occasionally have led to clinically apparent acute liver injury.

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References

    1. Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.(Review of hepatotoxicity published in 1999 before the availability of small molecule enzyme inhibitors such as olutasidenib).
    1. DeLeve LD. Erlotinib. Cancer chemotherapy. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 556.(Review of hepatotoxicity of cancer chemotherapeutic agents discusses several tyrosine kinase enzyme inhibitors including imatinib, gefitinib, erlotinib and crizotinib, but not the isocitrate dehydrogenase inhibitors such as olutasidenib).
    1. Wellstein A, Giaccone G, Atkins MB, Sausville EA. Pathway-targeted therapies: monoclonal antibodies, protein kinase inhibitors, and various small molecules. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1203-36.(Textbook of pharmacology and therapeutics).
    1. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215814Orig1s000M...(Integrated FDA review of the data on safety and efficacy of olutasidenib that formed the basis of its approval as therapy of adult with relapsed or refractory acute myelogenous leukemia, mentions that ALT elevations arose in 46% of patients, were above 5 times ULN in 11%, and that among 425 patients treated in two studies of olutasidenib, there were 19 cases of suspected drug induced liver injury, two of which were considered convincingly related to the drug, one of which was fatal).
    1. Watts JM, Baer MR, Yang J, Prebet T, Lee S, Schiller GJ, Dinner SN, et al. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial. Lancet Haematol. 2023;10:e46-e58.(Among 78 patients with AML or a myelodysplastic syndrome who were treated with olutasidenib with or without azacytidine, the objective response rate varied by indication and drug regimen from 25% to 77%, and adverse events were largely thrombocytopenia, febrile neutropenia and anemia; liver test abnormalities above 5 times the ULN arose in 10 patients [13%], led to discontinuation in 2 [3%], but ultimately resolved in all). - PubMed

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