Dr. Redner on the Potency of Gilteritinib in AML

Robert L. Redner, MD, a medical oncologist and hematologist, and professor of medicine, at the University of Pittsburgh Medical Center Hillman Cancer Center, discusses the potency of gilteritinib (Xospata) in acute myeloid leukemia (AML).

Gilteritinib is a FLT3 inhibitor that is FDA approved for patients with relapsed/refractory FLT3-positive AML. FLT3 is a tyrosine kinase growth factor receptor on normal hematopoietic cells and it is commonly mutated in AML; it is likely the most common driver mutation in patients with poor-risk disease. In the past, outcomes have been very poor for this population. Midostaurin (Rydapt) was the first FLT3 inhibitor that was approved, although it's indicated as frontline therapy in combination with an anthracycline and cytarabine.

Gilteritinib is currently only approved as a single agent based on its activity in the relapsed/refractory setting among patients who harbor the FLT3-ITD mutation or the FLT3 tyrosine kinase domain mutation. The agent is very active, but whether it is more active than midostaurin is unknown as there has never been a head-to-head comparison in combination with other chemotherapies. Ultimately, the role of gilteritinib will come down to whether or not it can be used in upfront therapy, concludes Redner.