On May 13, 2026, the FDA approved an all-oral combination of decitabine/cedazuridine (Inqovi) and venetoclax (Venclexta) for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or unable to receive intensive chemotherapy.
The approval was based on results from the phase 2 ASCERTAIN-V trial involving 101 patients. The study showed a complete remission rate of 41.6%, with patients reaching remission in a median of two months. Median overall survival was 15.5 months, and the median duration of remission had not yet been reached at the time of analysis.
The treatment offers a fully oral option for older or medically fragile patients who may not tolerate standard intensive therapy. Patients took one tablet of decitabine/cedazuridine daily for five days in a 28-day cycle, along with venetoclax using a standard dose ramp-up schedule.
Side effects were common and mainly related to low blood cell counts. Nearly all patients experienced severe treatment-related adverse events. Common side effects included fatigue, constipation, bleeding, nausea, and febrile neutropenia. Early mortality rates were 3% at 30 days and 9.9% at 60 days.