Taiho Oncology, Inc.

FDA Approves Oral Decitabine/Cedazuridine With Venetoclax in Newly Diagnosed AML

- The FDA approved oral decitabine and cedazuridine tablets (Inqovi, Taiho Oncology) with venetoclax for adults with newly diagnosed AML aged 75 or older or unfit for intensive induction chemotherapy. - Approval was based on the single-arm ASTX727-07 trial (NCT04657081) in 101 patients, which reported a complete remission rate of 41.6% and a median time to CR of 2 months. - The regimen is the first fully oral hypomethylating agent plus venetoclax combination for newly diagnosed AML, reviewed under Project Orbis with Health Canada and granted Orphan Drug Designation.