FDA approves all-oral decitabine/cedazuridine plus venetoclax for older or unfit AML patients

The FDA has granted approval for the combination of decitabine and cedazuridine (Inqovi) with venetoclax (Venclexta) to treat newly diagnosed acute myeloid leukemia in adults who are at least 75 years old or who cannot tolerate intensive induction chemotherapy.

Dr. Courtney DiNardo of MD Anderson highlighted that the approval introduces a fully oral regimen, offering a more convenient treatment option for patients who would otherwise face complex intravenous therapies.

The decision was based on the phase 2 ASCERTAIN‑V study, which reported a complete response rate of 41.6% and a median time to response of about two months. The median duration of response had not been reached at the time of reporting, indicating durable benefit in this population.