The US FDA has approved Taiho’s Inqovi plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukaemia (AML).
The approval is for patients who are 75 years or older or who are ineligible for intensive induction chemotherapy. Inqovi (decitabine and cedazuridine) 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.
Inqovi is an orally administered hypomethylating regimen previously approved in the U.S. and Canada for the treatment of adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).
Peter Melnyk, President and Chief Executive Officer of Taiho Oncology, said: “This FDA approval represents a significant milestone for patients with newly diagnosed acute myeloid leukaemia 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 haematologic malignancies.”
In 2026, an estimated 22,720 people in the U.S. 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, Chief Medical Officer of Taiho Oncology, said: “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.”