Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that FLT3-ITD status confers therapeutic sensitivity to Cytarabine, Idarubicin, Quizartinib in patients with Acute Myeloid Leukemia.

This statement is based on a regulatory approval from the Food and Drug Administration:

VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

Citation

Daiichi Sankyo, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216993s001lbl.pdf. Revised June 2024. Accessed October 3, 2025.