Regulatory approval
Published by the Health Service Executive. Approved
As monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. In the event that patients re-initiate gilteritinib post haematopoietic stem cell transplant (HSCT) as maintenance therapy, gilteritinib treatment should be restricted to patients who are minimal residual disease (MRD)-positive post-transplant.
This is written in the approval document.
Reimbursement
CDS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | FLT3-ITD | Acute Myeloid Leukemia | Gilteritinib | |
| HSE (1) | FLT3 p.D835Y | Acute Myeloid Leukemia | Gilteritinib |