Japan-based Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced on Wednesday that the US Food and Drug Administration (FDA) has accepted their supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive induction chemotherapy.

The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of 25 February 2026.

The sNDA is supported by results from ASCERTAIN-V, a Phase 2b study of INQOVI plus venetoclax in 101 adult patients with newly diagnosed AML who were ineligible for intensive induction chemotherapy.

INQOVI is an orally administrated hypomethylating regimen, currently indicated in the United States for the treatment of adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukaemia (CMML).

In each 28-day treatment cycle, the patients received INQOVI on days one through five and venetoclax daily. Median follow-up period was 11.2 months. The company says that the trial met its primary endpoint with a complete response (CR) rate of 46.5% (n=47).

Results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2025 European Hematology Association (EHA) Congress.