Approved gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).

Trade name Xospata.

ADMIRAL study, in which 138 adult patients with FLT3-positive relapsed/refractory AML received gilteritinib orally at 120 mg daily: rate of complete remission (CR) or CR with partial hematologic recovery (CRh) was 21% at a median follow-up of 4.6 months.

The CR rate was 11.6%.

Resulted in significantly longer survival and higher percentages of patients with remission than salvage chemotherapy among patients with relapse or refractory FLT 3-mutated AML (Perl AE).

Adverse events occurring in at least 20% of patients receiving gilteritinib included myalgia/arthralgia, transaminase increase, fatigue/malaise, fever, noninfectious diarrhea, dyspnea, edema, rash, pneumonia, nausea, stomatitis, cough, headache, hypotension, dizziness, and vomiting.

Serious AEs were relatively rare, and include febrile neutropenia (39%), sepsis (14%), pneumonia (11%), acute renal failure (10%), pyrexia (8%), bacteremia (6%), and respiratory failure (6%), but only febrile neutropenia, acute renal failure, pyrexia, sepsis, and bacteremia were determined to be treatment-related.

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