Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3-ITD status confers therapeutic sensitivity to Gilteritinib in patients with Acute Myeloid Leukemia.
This statement is based on a regulatory approval from the Health Service Executive:
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.