Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that FLT3 p.D835Y status confers therapeutic sensitivity to Gilteritinib in patients with Acute Myeloid Leukemia.

The U.S. Food and Drug Administration granted approval to gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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. 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.

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.