Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3 p.D835Y 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.