Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HC (1) FLT3-ITD Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835Y Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835A Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835E Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835H Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835N Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835S Acute Myeloid Leukemia Gilteritinib
HC (1) FLT3 p.D835V Acute Myeloid Leukemia Gilteritinib