Gilteritinib (XOSPATA (R)) in Turkey: Early access program results
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info:eu-repo/semantics/openAccessAttribution-NonCommercial 4.0 Internationalhttps://creativecommons.org/licenses/by-nc/4.0/Date
2023Author
Doğu, Mehmet HilmiTekgündüz, Ali İrfan Emre
Deveci, Burak
Korkmaz, Gülten
Cömert, Melda
Sevindik, Ömür Gökmen
Yokuş, Osman
Serin, İstemi
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Doğu, M. H., Tekgündüz, A. İ. E., Deveci, B., Korkmaz, G., Cömert, M., Sevindik, Ö. G. ... Serin, İ. (2023). Gilteritinib (XOSPATA (R)) in Turkey: Early access program results. Mediterranean Journal of Hematology and Infectious Diseases, 15(1). https://doi.org/10.4084/MJHID.2023.031Abstract
Background And Objectives: Gilteritinib (XOSPATA (R), 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: This research aimed 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 held in Turkey in April 2020 (NCT03409081). Results: The research included 17 R/R AML patients who had received gilteritinib from seven centers. The overall response rate was 100%. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in one patient only (5.9%), leading to permanent treatment discontinuation. 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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Mediterranean Journal of Hematology and Infectious DiseasesVolume
15Issue
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