2 Information about gilteritinib

Marketing authorisation indication

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

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics.


2.3 The list price for gilteritinib is £14,188 per 28‑day pack (company submission). The company has a commercial arrangement. This makes gilteritinib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)