Xospata (gilteritinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Astellas Pharma US, Inc. Xospata (gilteritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211349s000lbl.pdf. Revised November 2018. Accessed October 6, 2026.

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Regulatory approvals

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

Indication Statements
XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. 8

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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