Dr. Komrokji Discusses the FDA Approval of Gilteritinib for FLT3+ AML

Rami D. Komrokji, MD
Published: Wednesday, Nov 28, 2018



Rami S. Komrokji, MD, principal investigator, MDS Research Consortium, Aplastic Anemia and MDS International Foundation, clinical director, Hematologic Malignancies, Moffitt Cancer Center, discusses the FDA approval of gilteritinib (Xospata) for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

Findings from the phase III ADMIRAL study supported this approval. This study is evaluating the gilteritinib versus salvage chemotherapy in adult patients with FLT3-positive relapsed/refractory AML. In results from a phase I/II dose-escalation (n = 23) and dose-expansion (n = 229), investigators concluded that the maximum-tolerated dose of gilteritinib was 300 mg daily and determined that the treatment was generally well tolerated. Among patients included in the safety analysis (n = 252), the most common grade 3/4 adverse events were febrile neutropenia (39%), anemia (24%), thrombocytopenia (13%), sepsis (11%), and pneumonia (11%).

This approval follows a October 2017 Fast Track designation for the use of this agent in patients with FLT3 mutation–positive relapsed or refractory AML.
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Rami S. Komrokji, MD, principal investigator, MDS Research Consortium, Aplastic Anemia and MDS International Foundation, clinical director, Hematologic Malignancies, Moffitt Cancer Center, discusses the FDA approval of gilteritinib (Xospata) for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

Findings from the phase III ADMIRAL study supported this approval. This study is evaluating the gilteritinib versus salvage chemotherapy in adult patients with FLT3-positive relapsed/refractory AML. In results from a phase I/II dose-escalation (n = 23) and dose-expansion (n = 229), investigators concluded that the maximum-tolerated dose of gilteritinib was 300 mg daily and determined that the treatment was generally well tolerated. Among patients included in the safety analysis (n = 252), the most common grade 3/4 adverse events were febrile neutropenia (39%), anemia (24%), thrombocytopenia (13%), sepsis (11%), and pneumonia (11%).

This approval follows a October 2017 Fast Track designation for the use of this agent in patients with FLT3 mutation–positive relapsed or refractory AML.



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