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FDA approves oral decitabine/cedazuridine + venetoclax for ND AML
On May 13, 2026, the U.S. Food and Drug Administration (FDA) approved decitabine/cedazuridine in combination with venetoclax for the treatment of patients with newly diagnosed (ND) acute myeloid leukemia (AML) who are aged ≥75 years or who have comorbidities that make them ineligible for intensive chemotherapy.1
The approval was supported by results from the phase II ASCERTAIN-V (NCT04657081) study, where 41.6% (95% confidence interval [CI], 31.9–51.8) of patients with ND AML unfit for intensive chemotherapy (N = 101) achieved a complete response (CR), with a median time to CR of 2 months.1 The median duration of CR was not reached.1 Treatment-related adverse events (TRAEs) of any grade occurred in 80.2% of patients, and Grade ≥3 TRAEs occurred in 72.3% of patients.1 The most common any-grade TRAEs were anemia (32.7%), decreased platelet count (26.7%), neutropenia (25.7%), febrile neutropenia (24.8%), thrombocytopenia (21.8%), decreased neutrophil count (20.8%), nausea (19.8%), decreased appetite (17.8%), and decreased white blood cell count (14.9%).1 Fatal adverse events occurred in 15.8% of patients.1
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