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.

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