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.

View API

Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) FLT3 p.D835A Acute Lymphoid Leukemia Gilteritinib
HC (1) FLT3 p.D835E Acute Lymphoid Leukemia Gilteritinib
HC (1) FLT3 p.D835H Acute Lymphoid Leukemia Gilteritinib
HC (1) FLT3 p.D835N Acute Lymphoid Leukemia Gilteritinib
HC (1) FLT3 p.D835S Acute Lymphoid Leukemia Gilteritinib
HC (1) FLT3 p.D835V Acute Lymphoid Leukemia Gilteritinib
HC (1) FLT3-ITD Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835Y Acute Myeloid Leukemia Gilteritinib