Adding venetoclax to fludarabine, cytarabine, and idarubicin (FLA-IDA) may improve overall response rates, but not survival rates, among patients with relapsed or refractory acute myeloid leukemia (AML), according to the results of a retrospective cohort study published in Haematologica.

Venetoclax has demonstrated efficacy in the AML space previously, especially among patients unfit for intensive therapy. For this study, researchers evaluated whether adding venetoclax to FLA-IDA (FLAVIDA) improves outcomes compared with FLA-IDA only, as measured retrospectively.

Overall, data from 118 patients were included, among whom 37 received FLAVIDA and 81 received FLA-IDA. At baseline, in the FLAVIDA and FLA-IDA groups, the median ages were 54 and 52 years, respectively, 57% and 56% of patients were male sex, and 70% and 77% of patients had de novo AML.

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Analysis showed that the overall response rates in the FLAVIDA vs FLA-IDA groups were 78% vs 47%, respectively (P =.001); the minimal residual disease­–negativity rates were, however, similar (50% vs 57%). Event-free survival and overall survival, furthermore, appeared similar, and there was no difference in the proportion of patients that proceeded to transplantation or donor lymphocyte infusion. Toxicity rates were also similar.

Furthermore, FLA-IDA was linked with an improved salvage therapy success rate among patients with refractory disease. “In light of comparable toxicity this currently argues for the continued use of FLAVIDA in relapsed and refractory AML patients who are eligible for allogeneic transplantation,” the authors wrote in their report.

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.


Shahswar R, Beutel G, Gabdoulline R, et al. Fludarabine, cytarabine, and idarubicin with or without venetoclax in patients with relapsed/refractory acute myeloid leukemia. Haematologica. Published online July 20, 2023. doi:10.3324/haematol.2023.282912