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.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2019-10-24	European Medicines Agency	Indication received approval from the European Commission.