FDA approves oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
The FDA approved oral decitabine and cedazuridine tablets (Inqovi) plus venetoclax (Venclexta) for patients 75 years and older with newly diagnosed acute myeloid leukemia (AML). The regimen is also indicated for patients with comorbidities that make them ineligible for intensive induction chemotherapy.
Supporting data for the approval came from the phase 1/2 ASTX727-07 study (NCT04657081), in which investigators evaluated the regimen among 101 evaluable patients. The treatment regimen produced complete responses (CRs) in 41.6% (n = 42; 95% CI, 31.9%-51.8%) of patients. Additionally, the median time to CR was 2 months (range, 0.4-15.3), and the median duration of CR was not reached (range, 0.5-16.3).
The trial’s primary end points included the CR rate and pharmacokinetics. Secondary end points included time to response, duration of response, and overall survival.
The regimen’s prescribing information includes warnings and precautions for embryo-fetal toxicity and myelosuppression. The FDA approved the tablets at a dosage of 35 mg of decitabine and 100 mg of cedazuridine taken orally once daily on days 1 to 5 of each 28-day cycle until progressive disease or unacceptable toxicity.