following a full submission assessed under the end of life and orphan medicine process:
gilteritinib (Xospata®) is accepted for use within NHSScotland.
Indication under review: as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.
In an open-label, phase III study, gilteritinib improved overall survival compared with salvage chemotherapy in patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- gilteritinib (Xospata)
- SMC ID:
- SMC2252
- Indication:
Monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.
- Pharmaceutical company
- Astellas Pharma Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 07 September 2020