FDA
FDA approves Inqovi plus venetoclax as first all-oral AML regimen
Patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or not candidates for intensive induction chemotherapy now have a an all-oral treatment option. On May 13, 2026, FDA approved Inqovi (decitabine and cedazuridine) in combination with venetoclax for this population, expanding treatment beyond clinic-based hypomethylating agent regimens.
Clinically, this approval is important because many patients with AML are unable to tolerate intensive induction, yet standard low-intensity regimens often require frequent parenteral therapy visits. Inqovi is already approved for myelodysplastic syndromes and chronic myelomonocytic leukemia, and this new indication gives clinicians an oral backbone that can be combined with venetoclax in newly diagnosed AML.
FDA based the approval on data from the ASCERTAIN-V study. In combination with venetoclax, 41.6% of patients achieved complete remission, with a median time to complete remission of 2 months. Median duration of complete remission wasn't reached (range, 0.5 to 16.3 months).
The Inqovi prescribing information includes warnings and precautions for myelosuppression and embryo-fetal toxicity. Serious infections, febrile neutropenia, thrombocytopenia, anemia, and sepsis were common in the AML study population, and clinicians are advised to monitor blood counts closely and provide supportive care as appropriate.
“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," said Harold Keer, MD, PhD, chief medical officer of Taiho Oncology. "We believe this approach has the potential to make a meaningful impact for patients and caregivers.”
Sources:
Taiho Oncology, Inc. (2026, May 13). Press release. U.S. FDA approves INQOVI in combination with venetoclax, the first all-oral combination treatment for patients with acute myeloid leukemia who are ineligible for intensive induction chemotherapy
U.S. Food and Drug Administration. (2026, May 13). Press release. FDA approves INQOVI in combination with venetoclax, the first all-oral combination treatment for patients with acute myeloid leukemia who are ineligible for intensive induction chemotherapy