Xospata (gilteritinib) [product information]. EMA.
Regulatory approval published by the European Medicines Agency.
Citation
Astellas Pharma Europe B.V. Xospata (gilteritinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/xospata-epar-product-information_en.pdf. Revised November 2023. Accessed March 26, 2024.Regulatory approvals
Approved indications from this document for cancer drugs containing at least one biomarker.
| Indication | Statements |
|---|---|
| Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. | 2 |
Therapeutic response
Precision oncology relationships for therapeutic response derived from this document.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | FLT3-ITD | Acute Myeloid Leukemia | Gilteritinib | |
| Sensitivity (+) | FLT3 p.D835Y | Acute Myeloid Leukemia | Gilteritinib |