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Updated: Jul 30, 2025
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Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
Published on: April 7, 2023
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Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results
Mehmet Hilmi Dogu1, Ali Irfan Emre Tekgunduz2, Burak Deveci3
1Department of Hematology, Istinye University, Faculty of Medicine, Liv Hospital Ulus, Istanbul, Turkey.
Summary
Gilteritinib shows 100% response in FLT3-mutated relapsed/refractory AML patients. However, febrile neutropenia and peripheral edema indicate a high risk of death, necessitating careful monitoring.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Gilteritinib is an oral FLT3 inhibitor used for relapsed/refractory (R/R) acute myeloid leukemia (AML).
- The ADMIRAL trial demonstrated gilteritinib's superior efficacy in FLT3-mutated R/R AML patients.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of gilteritinib.
- To assess gilteritinib treatment in FLT3-positive R/R AML patients in Turkey.
Main Methods:
- Retrospective analysis of 17 R/R AML patients treated with gilteritinib.
- Data collected from seven centers as part of an early access program.
Main Results:
- 100% overall response rate observed.
- Most common adverse events: anemia and hypokalemia (41.2%).
- Peripheral edema was associated with a significantly higher risk of death (p<0.05).
Conclusions:
- Gilteritinib demonstrated high efficacy in this R/R AML cohort.
- Febrile neutropenia and peripheral edema are critical adverse events predicting poor survival.
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