Xospata (gilteritinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 8

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
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
Sensitivity (+) FLT3-ITD Acute Myeloid Leukemia Gilteritinib
Sensitivity (+) FLT3 p.D835Y Acute Myeloid Leukemia Gilteritinib