Regulatory approval

Published by the European Medicines Agency. Approved

Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

This is written in the approval document.

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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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
EMA (1) FLT3-ITD Acute Myeloid Leukemia Gilteritinib
EMA (1) FLT3 p.D835Y Acute Myeloid Leukemia Gilteritinib