Astellas Pharma’s gilteritinib is under priority review in the US as potential treatment for adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
The drug, discovered by Astellas and developed with partner Kotobuki, has the potential to be a first-in-class therapy given that there are currently no FLT3-targeting agents approved for the treatment of relapsed or refractory FLT3 mutation-positive (FLT3mut+) AML.
“FLT3 mutations impact approximately 30 percent of AML patients and are often associated with poor survival outcomes. Many with this condition relapse after treatment or don’t respond to currently available treatments. Simply put, they need more options,” said Steven Benner, senior vice president and global therapeutic area head, Oncology Development, Astellas.
“The FDA’s acceptance of this NDA, with Priority Review, represents a significant milestone for gilteritinib and Astellas in our mission to help AML patients and the physicians who treat them.”
The submission includes data from the Phase III ADMIRAL trial, an open-label, multicenter, randomised study of gilteritinib versus salvage chemotherapy in adult patients with FLT3 mutations who are refractory to or have relapsed after first-line AML therapy.
The co-primary endpoints of the trial are OS (Overall Survival) and CR (complete remission) / CRh (CR with partial hematological recovery) rate and the study is still ongoing.
Gilteritinib holds orphan status in both the EU and the US.