Xospata (gilteritinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Astellas Pharma US, Inc. Xospata (gilteritinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211349s003lbl.pdf. Revised January 2022. Accessed October 30, 2024.

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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.

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