Taiho Oncology, Inc. and Taiho Pharmaceutical have announced that the US Food and Drug Administration (FDA) has approved INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed Acute Myeloid Leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy. INQOVI, in combination with venetoclax, is the first and only all-oral combination treatment regimen approved for this patient population, offering an alternative to parenteral hypomethylating agent–based regimens that require frequent clinic visits.

The approval was supported by results from the phase 2 ASCERTAIN-V study of INQOVI plus venetoclax in adult patients with newly diagnosed AML who were ineligible for intensive induction chemotherapy.

Efficacy was established based on Complete Remission (CR) and the duration of CR (DoCR). Duration of remission was defined as the time from first CR until disease relapse or death from any cause, whichever occurred first. In combination with venetoclax, 42 patients achieved a CR (41.6 percent, 95 percent CI: 31.9, 51.8) with a median time to CR of two months (range: 0.4 to 15.3 months). The median duration of CR was not reached (range: 0.5 to 16.3 months).

INQOVI is an orally administered hypomethylating regimen previously approved in the US and Canada for the treatment of adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

Peter Melnyk, President and Chief Executive Officer (CEO), Taiho Oncology, said, “This FDA approval represents a significant milestone for patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction chemotherapy. With the approval of an all-oral regimen, INQOVI in combination with venetoclax brings a new treatment option to this patient population and underscores our commitment to advancing innovative, patient-focused therapies in hematologic malignancies.”

In 2026, an estimated 22,720 people in the US will be diagnosed with AML, a cancer of the blood and bone marrow. More than half of those patients are likely to be ineligible for intensive induction chemotherapy due to advanced age or health concerns.

Harold Keer, MD, PhD, Chief Medical Officer (CMO), Taiho Oncology, said, “As a leader in the development of oral anti-cancer regimens, we are proud that INQOVI, in combination with venetoclax, will now be available for newly diagnosed patients with acute myeloid leukemia in the US. This approval marks an important step forward in expanding how treatment can be delivered for this patient population, offering an all?oral option that can potentially reduce the overall treatment burden associated with receiving treatment in hospitals or infusion centers. We believe this approach has the potential to make a meaningful impact for patients and caregivers.”