← Back to The Docket MAY 13 2026
APPROVED · 139 DAYS AGO
— Inqovi (decitabine/cedazuridine)
for acute myeloid leukemia ineligible for intensive induction chemotherapy
NDA
FDA approved Inqovi (decitabine/cedazuridine) plus venetoclax for acute myeloid leukemia patients ineligible for intensive induction chemotherapy.
About
Acute myeloid leukemia is a rapidly progressing blood cancer that disrupts normal blood cell production. Inqovi is an oral tablet combining decitabine, which interferes with cancer cell DNA, with cedazuridine to help the drug be absorbed properly. This oral combination may provide a treatment option for those who cannot tolerate the intensive chemotherapy typically used first.
Pivotal trial
PREFER-HMA Phase 3 active not recruiting NCT05883956 It is hypothesized that significantly more patients would prefer oral decitabine/cedazuridine to subcutaneous (SC) azacitidine (AZA) due to several factors, including improved treatment convenience, the reduced risk of nosocomial infections, and reduced treatment discomfort. However, this hypothesis has not been formally studied in a controlled setting
Source: ClinicalTrials.gov