FDA accepts Taiho’s sNDA for Inqovi

The US Food and Drug Administration (FDA) has accepted the supplemental new drug application (sNDA) for Inqovi (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.

The sNDA was submitted by Taiho Oncology, alongside Taiho Pharmaceutical (TYO: 4581), an indirect subsidiary of Japan’s Otsuka (TYO: 4578).

If approved, this combination therapy would offer the first all-oral alternative to current therapies. The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.