On May 13, 2026, Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved decitabine and cedazuridine combination tablet (Inqovi) in combination with venetoclax tablet (Venetoclax) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy. Decitabine and cedazuridine combination tablet (Inqovi) plus venetoclax (Venetoclax) is the first and only all-oral combination therapy approved for this patient population, offering an alternative to hypomethylating agent regimens that require frequent clinic visits for parenteral (injectable) administration.
Basis of Approval: Data from the ASCERTAIN-V Clinical Trial
This approval is based on data from the ASCERTAIN-V clinical study. This Phase II study evaluated the efficacy and safety of decitabine and cedazuridine combination tablet (Inqovi) plus venetoclax (Venetoclax) in adult patients with newly diagnosed AML who were unfit for intensive induction chemotherapy. Results showed that the combination regimen achieved the complete remission (CR) endpoint, and no new safety concerns were reported.
Efficacy Results: Complete Remission Rate and Duration of Remission
Complete remission (CR) rate: 42 patients achieved CR (41.6%, 95% CI: 31.9–51.8%);
Median time to CR: 2 months (range: 0.4–15.3 months);
Median duration of CR: not reached (range: 0.5–16.3 months);
Duration of remission is defined as the time from first CR to disease relapse or death from any cause, whichever occurs first.
Summary of Important Safety Information
The prescribing information includes warnings and precautions regarding myelosuppression and embryo-fetal toxicity. The following is a summary of key safety information:
1. Myelosuppression (when venetoclax is used in combination for AML)
New or worsening thrombocytopenia: 70% (Grade 3/4: 69%);
Neutropenia: 48% (Grade 3/4: 48%);
Anemia: 54% (Grade 3/4: 50%);
Febrile neutropenia: 52% (Grade 3/4: 52%);
Serious infections: Pneumonia (25%, Grade 3/4: 20%), Sepsis (28%, Grade 3/4: 18%); Fatal pneumonia 2%, fatal sepsis 8%;
2. Embryo-Fetal Toxicity
Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose;
Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.
3. Most Common Adverse Reactions (≥20%, with venetoclax)
Neutropenia (60%), febrile neutropenia (52%), thrombocytopenia (52%), hemorrhage (42%), anemia (41%), infection (bacterial/viral, 40%), diarrhea (38%), fatigue (36%), mucositis (36%), constipation (36%), arthralgia (35%), decreased appetite (31%), edema (31%), nausea (31%), dyspnea (30%), leukopenia (28%), sepsis (28%), pneumonia (25%), rash (25%), elevated transaminases (24%), myalgia (23%), arrhythmia (21%), abdominal pain (21%).
