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MAY 13 2026
APPROVED · 21 DAYS AGO

Taiho Oncology, Inc. 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 an aggressive blood cancer where abnormal white blood cells multiply uncontrollably, crowding out healthy cells and impairing normal blood function. Inqovi combines decitabine, which disrupts cancer cell growth by altering DNA, with cedazuridine, a compound that helps maintain decitabine's activity in the body. This oral combination may offer a less intensive treatment option for patients who cannot tolerate standard chemotherapy, potentially slowing disease progression.

Pivotal trial

NCT03306264 Phase 3 completed NCT03306264

Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m\^2 Daily×5 in Cycle 2, or the converse order

Source: ClinicalTrials.gov

Also in development