Original Articles
Vol. 15 No. 1 (2023): Review Articles, Original Article, Scientific Letter, Case Reports Letter to the Editor
GILTERITINIB (XOSPATA ®) IN TURKEY: EARLY ACCESS PROGRAM RESULTS
Gilteritinib (XOSPATA ®) in Turkey
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Received: February 27, 2023
Accepted: April 12, 2023
Accepted: April 12, 2023
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Background: Gilteritinib (XOSPATA ®, Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute myeloid leukemia (AML) patients who harbored any FLT3 mutation and showed superior efficacy with regard to response and survival. Objectives: The purpose of this research was to investigate the real-life efficacy and safety of gilteritinib in FLT3-positive R/R AML patients who were treated as a part of an early access program that was held in Turkey starting in April 2020 (NCT03409081). Results: The research included 17 R/R AML patients who had received gilteritinib from a total of 7 centers. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in only one patient (5.9%), which led to permanent discontinuation of treatment. The overall response rate was 100%. Patients with peripheral edema had a 10.47 (95% CI: 1.64-66.82) times higher risk of death than those without peripheral edema (p<0.05). Conclusion: This research showed that patients with febrile neutropenia and peripheral edema were at a high risk of death when compared to patients without febrile neutropenia and peripheral edema.
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How to Cite
“GILTERITINIB (XOSPATA ®) IN TURKEY: EARLY ACCESS PROGRAM RESULTS: Gilteritinib (XOSPATA ®) in Turkey” (2023) Mediterranean Journal of Hematology and Infectious Diseases, 15(1), p. e2023031. doi:10.4084/MJHID.2023.031.
Copyright (c) 2023 Mehmet Hilmi DOGU, Ali Irfan Emre TEKGUNDUZ, Burak DEVECI, Gulten KORKMAZ, Melda COMERT, Omur Gokmen SEVINDIK, Osman YOKUS, Istemi SERIN
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
