FDA Approves Oral Combination of Decitabine and Cedazuridine Tablets with Venetoclax for Newly Diagnosed AML
esmo - Evidence for efficacy is based on the results from the Study ASTX727-07
AI Summary: The FDA has approved an oral combination (decitabine/cedazuridine plus venetoclax) as a treatment option for newly diagnosed acute myeloid leukemia patients who are older or unfit for intensive therapy. The approval offers an at-home alternative to frequent infusions, potentially reducing clinic visits and improving convenience for a vulnerable population.
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- Experts celebrate all-oral AML option online (3)
- FDA approval and ASCERTAIN V trial evidence (3)
- Targeted therapies and regimen optimization in AML (3)
Experts celebrate all-oral AML option online
FDA approval and ASCERTAIN V trial evidence
Targeted therapies and regimen optimization in AML
Blog Post
FDA has approved the first all‑oral regimen for certain newly diagnosed acute myeloid leukemia (AML) patients: oral decitabine/cedazuridine tablets combined with venetoclax for patients who are older or otherwise unfit for intensive therapy. Approval is supported by data from Study ASTX727‑07 and the ASCERTAIN V trial, which reported strong response rates and favorable survival outcomes, and offers an at‑home alternative to repeated IV/infusion visits. Researchers including co‑authors Talha Badar and Amer Zeidan have highlighted the significance of this option for a vulnerable population.
Sources: ESMO (ASTX727‑07) and MedicalXpress (ASCERTAIN V) — https://www.esmo.org/oncology-news/fda-approves-oral-combination-of-decitabine-and-cedazuridine-tablets-with-venetoclax-for-newly-diagnosed-aml ; https://medicalxpress.com/news/2026-06-fda-oral-aml-therapy-older.html