Regulatory approval

Published by the Health Canada.

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 is written in the approval document as:

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835Y	Acute Myeloid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835A	Acute Lymphoid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835E	Acute Lymphoid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835H	Acute Lymphoid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835N	Acute Lymphoid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835S	Acute Lymphoid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835V	Acute Lymphoid Leukemia	Gilteritinib