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  6. FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
  1. Resources for Information | Approved Drugs

FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia

On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

Full prescribing information for Inqovi will be posted on  Drugs@FDA . 

Efficacy and Safety

Efficacy was evaluated in Study ASTX727-07 (NCT04657081), a single arm, open-label clinical trial of decitabine and cedazuridine tablets in combination with venetoclax in adults with newly diagnosed AML who were age 75 years or older or had comorbidities that precluded the use of intensive induction chemotherapy (n=101). Efficacy was established based on complete remission (CR) and the duration of CR (DoCR). Duration of remission was defined as the time from first CR until disease relapse or death from any cause, whichever occurred first. In combination with venetoclax, 42 patients achieved a CR (41.6%, 95% CI: 31.9, 51.8) with a median time to CR of two months (range: 0.4 to 15.3 months). The median duration of CR was not reached (range: 0.5 to 16.3 months). 

The prescribing information includes warnings and precautions for myelosuppression and embryo-fetal toxicity.

Recommended Dosage

The recommended Inqovi dose in combination with venetoclax is one tablet (containing 35 mg decitabine and 100 mg cedazuridine) orally once daily on Days 1 through 5 of each 28-day cycle until disease progression or unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada. The applications may still be under review at the other regulatory agencies.

Decitabine and cedazuridine received an orphan drug designation for this indication.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov .

Follow the Oncology Center of Excellence on X: @FDAOncology.

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