Therapeutic Response Statement (Sensitivity)

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

This statement is based on a regulatory approval from the Health Canada:

XOSPATA (gilteritinib tablets) is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation.

Citation

Astellas Pharma Canada, Inc. Xospata (gilteritinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00064190.PDF. Revised January 2022. Accessed June 2025.