Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3 p.D835A status confers therapeutic sensitivity to Gilteritinib in patients with Acute Lymphoid Leukemia.
Health Canada approved gilteritinib for the treatment of adult patients who have relapsed or refactory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation.
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.