Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. Gilteritinib's product information states that, before taking gilteritinib, relapsed or refactory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. The product information describes the mechanism of action for gilteritinib as inhibiting FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and that it induces apoptosis in leukemic cells expressing FLT3-ITD.

This is written in the approval document as:

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

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835Y	Acute Myeloid Leukemia	Gilteritinib