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Gilteritinib Monotherapy Shows Potential for Treatment of Relapsed/Refractory FLT3+ AML

Mark J. Levis, MD, PhD
Published Online:7:55 PM, Thu August 8, 2019

Patients with relapsed or refractory acute myeloid leukemia (AML) typically have low response rates to chemotherapy. However, some subsets of patients, particularly those with targetable mutations, may have long-term survival when given a novel FLT3 inhibitor like gilteritinib (Xospata), as seen in the ADMIRAL trial (NCT02421939), says Mark J. Levis, MD, PhD, program leader, Hematologic Malignancies and Bone Marrow Transplant Program, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine.

Patients with FLT3-mutant relapsed/refractory AML treated with gilteritinib in the ADMIRAL trial showed a median overall survival of 9.3 months compared with 5.6 months in those treated with salvage chemotherapy. The risk of death was reduced by 36% with the use of the FLT3 inhibitor.
Being able to target relapsed AML with gilteritinib monotherapy depends on how severe the mutation is, says Levis. In some cases, bone marrow transplant may be prevented if the patient is highly responsive to gilteritinib. The challenge, Levis believes, is understanding why multiple mutations occur.
More lab-based research is needed to decide whether or not gilteritinib monotherapy is appropriate for patients with relapsed or refractory AML.
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