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Gilteritinib for treating relapsed or refractory acute myeloid leukaemia

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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 recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily. Treatment should continue until the patient is no longer clinically benefiting from gilteritinib or until unacceptable toxicity occurs. The summary of product characteristics states that response may be delayed; therefore, continuation of treatment at the prescribed dose for up to 6 months should be considered to allow time for a clinical response. In the absence of a response after 4 weeks of treatment, the dose can be increased to 200 mg (five 40 mg tablets) once daily, if tolerated or clinically warranted.

Price

2.3 The list price for gilteritinib is £14,188 per 28‑day pack (company submission). Multiple courses of treatment will be used. The company has a commercial arrangement, which would have applied if the technology had been recommended.