← Back to The Docket MAY 13 2026
APPROVED · 79 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
Inqovi is an oral drug that pairs decitabine, a cancer-cell killer, with cedazuridine, a helper molecule that lets decitabine survive digestion and reach the bloodstream. Since induction chemotherapy for acute myeloid leukemia can be too intense for some patients, this tablet could offer a less aggressive way to administer the treatment.
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