FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
Regulatory approval: On May 13, 2026, the FDA approved oral decitabine/cedazuridine tablets (Inqovi) in combination with venetoclax for adults with newly diagnosed AML who are ≥75 years or have comorbidities precluding intensive induction chemotherapy. Approval was based on the single-arm, open-label ASTX727-07 trial (n=101), with complete remission (CR) 41.6% (95% CI 31.9–51.8) and median duration of CR not reached. Label warnings include myelosuppression and embryo-fetal toxicity.
FDA approval (May 13, 2026): oral decitabine/cedazuridine tablets + venetoclax in newly diagnosed AML
The US FDA granted a regulatory approval on May 13, 2026 for an oral combination of decitabine and cedazuridine tablets (Inqovi; Taiho Oncology, Inc.) with venetoclax for newly diagnosed acute myeloid leukemia (AML) in adults aged ≥75 years, or adults with comorbidities that preclude intensive induction chemotherapy.
Evidence supporting approval
Efficacy and safety were evaluated in ASTX727-07 (NCT04657081), a single-arm, open-label study of decitabine/cedazuridine tablets plus venetoclax in this population (n=101). The FDA cited complete remission (CR) and duration of CR (DoCR) as efficacy endpoints.
- CR: 42 patients; 41.6% (95% CI 31.9–51.8)
- Median time to CR: 2 months (range 0.4–15.3)
- Median DoCR: not reached (range 0.5–16.3); DoCR defined from first CR to relapse or death
Key labeling and dosing notes
The prescribing information includes warnings/precautions for myelosuppression and embryo-fetal toxicity.
Recommended dose (with venetoclax): 1 tablet (35 mg decitabine/100 mg cedazuridine) orally once daily on Days 1–5 of each 28-day cycle, until disease progression or unacceptable toxicity.
The review was conducted under Project Orbis (FDA collaboration with Health Canada); other agencies may still be reviewing. The combination received orphan drug designation for this indication.