Posted by Michael Wonder on 13 May 2026
FDA approves oral combination of decitabine and cedazuridine tablets with venetoclax for newly diagnosed acute myeloid leukemia
13 May 2026 - Today, the FDA approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology) with venetoclax for the treatment of newly diagnosed acute myeloid leukaemia in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Efficacy was evaluated in Study ASTX727-07, a single-arm, open-label clinical trial of decitabine and cedazuridine tablets in combination with venetoclax in adults with newly diagnosed acute myeloid leukaemia who were age 75 years or older or had co-morbidities that precluded the use of intensive induction chemotherapy (n=101).
