PRINCETON, N.J. and TOKYO, May 13, 2026
Taiho Oncology and Taiho Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has approved INQOVI® (decitabine and cedazuridine) in combination with venetoclax for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are either 75 years or older or are ineligible for intensive induction chemotherapy. The approval marks the first and only all-oral combination regimen available for this AML patient population, offering a major advancement in treatment convenience and accessibility for patients unable to tolerate intensive hospital-based therapies.
The regulatory approval was supported by positive findings from the Phase 2 ASCERTAIN-V clinical study, which demonstrated that the INQOVI plus venetoclax combination achieved significant complete remission outcomes in newly diagnosed AML patients while maintaining a manageable safety profile. Company executives stated that the approval reflects growing demand for patient-focused oncology therapies capable of reducing treatment burden while maintaining clinical effectiveness.
ASCERTAIN-V Trial Demonstrated Strong Clinical Responses
According to Taiho Oncology, efficacy in the ASCERTAIN-V study was established based on complete remission rates and duration of complete remission among adult AML patients who were not eligible for intensive induction chemotherapy. Clinical investigators reported that 42 patients achieved complete remission, representing a remission rate of 41.6%, with a median time to remission of approximately two months.
The company stated that the median duration of complete remission had not yet been reached at the time of analysis, suggesting durable therapeutic activity among responding patients. Researchers emphasized that no unexpected safety concerns emerged during evaluation of the oral treatment combination.
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AML is an aggressive blood and bone marrow cancer that primarily affects older adults. Healthcare experts estimate that more than 22,000 new AML cases will be diagnosed in the United States during 2026, with a large proportion of patients unable to undergo intensive chemotherapy because of age, frailty, or underlying health conditions.
Traditional AML treatment regimens often require prolonged hospital visits and intravenous administration, creating substantial physical and logistical burdens for patients and caregivers. Taiho Oncology stated that the availability of a fully oral treatment regimen may help reduce dependence on infusion centers and improve treatment accessibility for eligible patients.
All-Oral AML Therapy Expands Treatment Options
INQOVI is an orally administered fixed-dose combination of the DNA hypomethylating agent decitabine and cedazuridine, a cytidine deaminase inhibitor designed to enable oral delivery of decitabine while achieving systemic exposure comparable to intravenous administration.
The therapy had previously received FDA approval for the treatment of adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). The latest approval expands the therapeutic role of INQOVI into frontline treatment for newly diagnosed AML patients who are unsuitable for intensive induction chemotherapy.
Taiho Oncology leadership highlighted that the approval further reinforces the company’s position as a developer of innovative orally administered anti-cancer therapies focused on improving patient experience and expanding treatment flexibility within hematologic malignancies.
Healthcare analysts continue to identify oral oncology regimens as one of the fastest-growing areas within cancer therapeutics, driven by increasing demand for home-based treatment options, improved patient convenience, and reduced healthcare resource utilization.
Oncology Innovation Continues to Transform AML Care
The approval of INQOVI plus venetoclax reflects broader advancements in precision oncology and hematologic cancer treatment, where targeted therapies and combination regimens are increasingly replacing traditional high-intensity chemotherapy approaches for vulnerable patient populations.
Industry experts note that elderly AML patients often face limited treatment options due to toxicity risks associated with intensive induction regimens. The introduction of effective oral therapies capable of delivering clinically meaningful remission rates may significantly improve treatment accessibility and quality of life for patients requiring less intensive care approaches.
Taiho Oncology stated that the FDA approval underscores the company’s long-term commitment to developing innovative cancer therapies capable of addressing major unmet needs in blood cancers and hematologic malignancies while advancing more patient-centered approaches to oncology treatment delivery.
Source: Taiho Oncology press release
