Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

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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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) FLT3-ITD Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835Y Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835A Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835E Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835H Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835N Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835S Acute Myeloid Leukemia Gilteritinib
FDA (2) FLT3 p.D835V Acute Myeloid Leukemia Gilteritinib

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2018-11-28 Food and Drug Administration Indication received traditional approval.