FDA Alert

FDA Approves Decitabine and Cedazuridine (Inqovi) With Venetoclax for Newly Diagnosed AML in Adults Aged 75 Years or Older or Ineligible for Intensive Induction Chemotherapy

Anthony Calabro, MA

Key Highlights

  • The FDA approved decitabine and cedazuridine (Inqovi) tablets in combination with venetoclax for newly diagnosed acute myeloid leukemia.
  • The approval applies to adults aged 75 years or older or adults with comorbidities that preclude intensive induction chemotherapy.
  • In Study ASTX727-07, 41.6% of patients achieved complete remission with the combination.
  • The prescribing information includes warnings and precautions for myelosuppression and embryo-fetal toxicity.

On May 13, the FDA approved oral decitabine and cedazuridine (Inqovi; Taiho Oncology, Inc) tablets in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults aged 75 years or older or in adults with comorbidities that preclude the use of intensive induction chemotherapy. The FDA granted orphan drug designation to decitabine and cedazuridine for this indication.

The approval was based on Study ASTX727-07, a single-arm, open-label clinical trial evaluating decitabine and cedazuridine tablets in combination with venetoclax in adults with newly diagnosed AML aged 75 years or older or with comorbidities that precluded intensive induction chemotherapy (N = 101). Efficacy was established based on complete remission (CR) and duration of CR. In combination with venetoclax, 42 patients achieved a CR, for a CR rate of 41.6% (95% CI, 31.9%-51.8%). The median time to CR was 2 months (range, 0.4-15.3 months), and the median duration of CR was not reached (range, 0.5-16.3 months).

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

The recommended dose of decitabine and cedazuridine, in combination with venetoclax, is 1 tablet containing 35 mg decitabine and 100 mg cedazuridine, taken orally once daily on days 1 through 5 of each 28-day cycle. Treatment should continue until disease progression or unacceptable toxicity.

Reference
US Food and Drug Administration. FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia. Published May 13, 2026. Accessed May 18, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute