Gilteritinib (Xospata) plus venetoclax and azacitidine in FLT3 mutated acute myeloid leukemia – pro
There is literature to supprt this regimen, especially for bridging of pateint whith refractory disease to transplantation.
XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test
Short in a phase I/II study et al found that the combination of azacitidine, venetoclax, and gilteritinib resulted in high rates of CR/CRi (there were very high CR results, 90% in first line), deep FLT3 molecular responses, and encouraging survival (90% at 6 months and 72% in 18 months in 10 months) in newly diagnosed FLT3-mutated AML.
Chen in a Poster showed similar results in 29 patients with induction failure, simiar to the claimant.
Bridging does not require long-term results, as it is merely to hold the disease in bay while arranging for a transplant. As such,a regimen with a high short-term efficacy is a good choice, even if long term results are not completely verified.
Nianci Chen, Real-world effectiveness and safety of gilteritinib plus venetoclax and azacitidine in FLT3 mutated acute myeloid leukemia . Blood (2025) 146 (Supplement 1): 5237.
DiNardo KW, LeBlanc TW, Chen H. Novel agents and regimens in acute myeloid leukemia: latest updates from 2022 ASH Annual Meeting. J Hematol Oncol. 2023 Mar 3;16(1):17. doi: 10.1186/s13045-023-01411-x. PMID: 36869366; PMCID: PMC9983204.
Short NJ, Daver N, Dinardo CD, Kadia T, Nasr LF, Macaron W, Yilmaz M, Borthakur G, Montalban-Bravo G, Garcia-Manero G, Issa GC, Chien KS, Jabbour E, Nasnas C, Huang X, Qiao W, Matthews J, Stojanik CJ, Patel KP, Abramova R, Thankachan J, Konopleva M, Kantarjian H, Ravandi F. Azacitidine, Venetoclax, and Gilteritinib in Newly Diagnosed and Relapsed or Refractory FLT3-Mutated AML. J Clin Oncol. 2024 May 1;42(13):1499-1508. doi: 10.1200/JCO.23.01911. Epub 2024 Jan 26. PMID: 38277619; PMCID: PMC11095865.