Taiho Oncology and Taiho Pharmaceutical Announce FDA Acceptance of Supplemental New Drug Application for INQOVI® in Combination with Venetoclax for AML Patients
[City, State] – July 9, 2025 – Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd. today announced a significant milestone in the treatment of acute myeloid leukemia (AML) with the U.S. Food and Drug Administration’s (FDA) acceptance of their Supplemental New Drug Application (sNDA) for INQOVI® (decitabine and cedazuridine) in combination with venetoclax. This combination therapy is being pursued for adult patients diagnosed with AML.
The acceptance of this sNDA marks a crucial step forward, signifying that the FDA will now review the submitted data to potentially expand the approved use of INQOVI®. The application is supported by robust clinical trial data demonstrating the efficacy and safety profile of INQOVI® when used in conjunction with venetoclax, a well-established treatment option for AML.
Acute myeloid leukemia is a complex and aggressive blood cancer that affects the bone marrow and blood. For many patients, particularly those who may not be candidates for intensive chemotherapy, novel and effective treatment approaches are critically needed. The development of this combination therapy represents a strategic effort to address this unmet medical need by offering a potentially synergistic approach to combatting AML.
INQOVI®, which received FDA approval in 2020, is an oral hypomethylating agent that offers patients a convenient administration route. Its mechanism of action involves altering DNA methylation patterns, which can help to restore normal gene function and induce differentiation or apoptosis of leukemic cells. Venetoclax, a BCL-2 inhibitor, works by promoting programmed cell death in cancer cells. The rationale behind combining these two agents is to leverage their distinct yet complementary mechanisms of action to achieve a more potent and durable anti-leukemic effect.
“We are encouraged by the FDA’s acceptance of our supplemental new drug application for INQOVI® in combination with venetoclax,” said [Name and Title of Taiho Oncology Spokesperson, if available, otherwise state Taiho Oncology]. “This development underscores our commitment to advancing the treatment landscape for patients with AML. We believe that the combination of INQOVI® and venetoclax holds significant promise in improving outcomes for these patients, and we look forward to working closely with the FDA throughout the review process.”
The sNDA submission is based on comprehensive clinical evidence, including data from [mention specific trial names or phases if known, e.g., Phase 3 clinical trials]. These trials have been designed to rigorously evaluate the safety and efficacy of the combination regimen in a targeted AML patient population.
Taiho Oncology and Taiho Pharmaceutical are dedicated to bringing innovative therapies to patients facing serious diseases. The potential approval of INQOVI® in combination with venetoclax would represent a significant advancement in the treatment of AML, offering a new therapeutic option that could benefit a broad range of patients. The companies express their gratitude to the patients, investigators, and healthcare professionals who have contributed to this important research.
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