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Review

Quizartinib

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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

Quizartinib

No authors listed.
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Excerpt

Quizartinib is an orally administered receptor tyrosine kinase FLT3 inhibitor that is used in combination with other cancer chemotherapeutic agents to treat adults with acute myelogenous leukemia who are positive for FLT3 internal tandem duplication. Quizartinib is associated with a high rate of liver enzyme elevations during therapy, but a similar rate occurs with comparator arms of chemotherapy, and it has not been shown to cause clinically apparent drug induced liver injury.

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References

    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. Integrated Review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216993Orig1s000M...(FDA website with initial multidiscipline clinical review of the safety and efficacy of quizartinib mentions that ALT elevations arose in 16% of recipients [vs 10% on placebo], but that alternative causes accounted for most abnormalities and all improved without dose modification or discontinuation and that there were no cases of hepatic failure or toxic hepatitis).
    1. Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, et al. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018;19(7):889-903.(Among 333 patients with relapsed or refractory breast cancer treated with quizartinib and standard chemotherapy, the composite complete response rate was 46-56% in those with FLT3-internal tandem duplication and 30-36% in those without, while serious adverse events were common including ALT elevations above 5 times ULN in 3% and fatal hepatic failure in 2 patients, both in the context of multiorgan failure and not attributed to quizartinib). - PMC - PubMed
    1. Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Krämer A, et al. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019;20:984-997.(Among 335 patients with relapsed or refractory breast cancer with FLT3-internal tandem duplication treated with quizartinib monotherapy or salvage chemotherapy, overall median survival was longer with quizartinib [6.2 vs 4.7 months] and total adverse event rates were similar, ALT elevations arose in 14% vs 4% and were above 5 times ULN in 3.7% vs 2%). - PubMed
    1. Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Žák P, Wang PN, Met al.; QuANTUM-First Study Group. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023;401(10388):1571-1583.(Among 539 adults with newly diagnosed AML and FLT3-internal tandem duplication treated with quizartinib or placebo in combination with standard chemotherapy for induction and consolidation followed by single agent quizartinib or placebo continuation, overall survival was greater with quizartinib [31.9 vs 15.1 months] and virtually all patients had at least one adverse event including ALT elevations in 16% vs 10%, which were above 5 times ULN in 5% vs 5%; there were no liver related deaths). - PubMed

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