Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| 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 |