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.

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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