News Releases

• Approval is based on data from the ASCERTAIN-V clinical trial demonstrating that INQOVI in combination with venetoclax met complete response endpoints, with no new safety concerns reported
• INQOVI is also approved in the U.S. as a treatment for myelodysplastic syndromes and chronic myelomonocytic leukemia

Taiho Pharmaceutical Co., Ltd. and its U.S. subsidiary, Taiho Oncology, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved INQOVI (decitabine and cedazuridine) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who are ineligible for intensive induction chemotherapy. INQOVI 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.¹

Efficacy was established based on complete remission (CR) and the duration of CR (DoCR). Duration of remission was defined as the time from first CR until disease relapse or death from any cause, whichever occurred first. In combination with venetoclax, 42 patients achieved a CR (41.6%, 95% CI: 31.9, 51.8) with a median time to CR of two months (range: 0.4 to 15.3 months). The median duration of CR was not reached (range: 0.5 to 16.3 months).

With regard to safety, the US Prescribing Information contains Warnings and Precautions for myelosuppression and embryo-fetal toxicity.

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).²

“This FDA approval represents a significant milestone for patients with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction chemotherapy,” said Peter Melnyk, President and Chief Executive Officer of Taiho Oncology. “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 hematologic 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.³ More than half of those patients are likely to be ineligible for intensive induction chemotherapy due to advanced age or health concerns.⁴

“As a leader in the development of oral anti-cancer regimens, we are proud that INQOVI in combination with venetoclax will now be available for newly diagnosed patients with acute myeloid leukemia in the U.S.,” said Harold Keer, MD, PhD, Chief Medical Officer of Taiho Oncology. “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.”

※ASCERTAIN-V: AStx727-07: decitabine + CEdazuRidine TreAtment IN AML, adding Venetoclax

INQOVI is an orally administered, fixed-dose combination of the DNA hypomethylating agent decitabine together with cedazuridine,⁵ an inhibitor of cytidine deaminase.⁶ By inhibiting cytidine deaminase in the gut and the liver, the fixed dose combination is designed to allow for the oral delivery of decitabine to achieve comparable systemic exposure to that of IV decitabine.

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives. For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/.

The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada.

For more information, visit https://www.taihooncology.com/, and follow us on LinkedIn and X.

Taiho Oncology and the Taiho Oncology logo are registered trademarks of Taiho Pharmaceutical Co., Ltd.

1. Zeidan A, Griffiths E, Dinardo C, et al. An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts. Presented at: the 2025 Annual Meeting of the American Society of Clinical Oncology; May 30-June 3, 2025; Chicago. Abstract 6504. https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6504.
2. Oncology Practice Management. FDA Approves Inqovi, a New Oral Combination Therapy, for Patients with MDS. Published July 7, 2020. Accessed October 10, 2025. https://oncpracticemanagement.com/issues/2020/august-2020-vol-10-no-8/1719-fda-approves-inqovi-a-new-oral-combination-therapy-for-patients-with-mds.
3. American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised January 13, 2026. Accessed March 27, 2026. https://www.cancer.org/cancer/types/acute-myeloid-leukemia/about/key-statistics.html.
4. Heuser M, Fernandez C, Hauch O, Klibanov OM, Chaudhary T, Rives V. Therapies for acute myeloid leukemia in patients ineligible for standard induction chemotherapy: a systematic review. Future Oncol. 2022;19(11):789-810. https://doi.org/10.2217/fon-2022-1286.
5. Oganesian A, Redkar S, Taverna P, Choy G, Joshi-Hangal R, Azab M. Preclinical data in cynomolgus (cyn) monkeys of ASTX727, a novel oral hypomethylating agent (HMA) composed of low-dose oral decitabine combined with a novel cytidine deaminase inhibitor (CDAi) E7727 [ASH Abstract]. Blood 2013;122(21): Abstract 2526. https://doi.org/10.1182/blood.V122.21.2526.2526.
6. Ferraris D, Duvall B, Delahanty G, et al. Design, synthesis, and pharmacological evaluation of fluorinated tetrahydrouridine derivatives as inhibitors of cytidine deaminase. J Med Chem. 2014; 57:2582-2588. DOI: 10.1021/jm401856k.