/PRNewswire/ -- Taiho Oncology, Inc., and Taiho Pharmaceutical Co., Ltd., announced today that the U.S. Food and Drug Administration (FDA) has accepted their 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.

/PRNewswire/ -- 大鹏制药有限公司（Taiho Oncology, Inc.）与大鹏制药株式会社（Taiho Pharmaceutical Co., Ltd.）今日宣布，美国食品药品监督管理局（FDA）已接受其补充新药申请（sNDA），涉及使用INQOVI（地西他滨和西达尿苷）联合维奈托克治疗新诊断的、不适合进行高强度诱导化疗的成人急性髓系白血病（AML）患者。

The FDA assigned a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of .

FDA 指定了一个标准审查，处方药使用者费用法案（PDUFA）目标行动日期为 。

February 25, 2026

2026年2月25日

The sNDA is supported by results from ASCERTAIN-V, a Phase

该补充新药申请（sNDA）得到了ASCERTAIN-V三期试验结果的支持，

study of INQOVI plus venetoclax in 101 adult patients with newly diagnosed AML who were ineligible for intensive induction chemotherapy.

INQOVI联合维奈托克在101名新诊断的不适合强化诱导化疗的成人AML患者中的研究。

INQOVI is an orally administrated hypomethylating regimen, currently indicated in the U.S. for the treatment of adults with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

INQOVI是一种口服的低甲基化治疗方案，目前在美国被批准用于治疗骨髓增生异常综合征（MDS）和慢性粒单核细胞白血病（CMML）成人患者。

Approximately 22,000 people in the U.S. will receive a diagnosis of AML, a cancer of the blood and bone marrow, in 2025.

预计到 2025 年，美国将有大约 22,000 人被诊断出患有急性髓系白血病（AML），这是一种血液和骨髓的癌症。

More than half those patients will likely be deemed ineligible for intensive induction chemotherapy.

超过一半的患者可能被认为不符合强化诱导化疗的条件。

'We have an unwavering dedication to developing innovative new cancer treatments, and the FDA's acceptance of our sNDA for INQOVI in combination with venetoclax highlights the need for novel approaches in AML,' said

“我们坚定不移地致力于开发创新的癌症新疗法，FDA接受我们关于INQOVI与维奈托克联合使用的补充新药申请，突显了在AML治疗中对新颖方法的需求，”

Harold Keer

哈罗德·基尔

, MD, PhD, Chief Medical Officer,

医学博士，哲学博士，首席医疗官，

Taiho Oncology

太陽製藥

. 'If approved for patients with AML who are not eligible to undergo intensive induction chemotherapy, INQOVI in combination with venetoclax would offer the first all-oral alternative to current therapies.'

“如果不适合接受强化诱导化疗的急性髓系白血病患者获得批准，INQOVI联合维奈托克将提供当前疗法的首个全口服替代方案。”

Summary of ASCERTAIN-V

ASCERTAIN-V 概述

Data

数据

In each 28-day treatment cycle, the patients received INQOVI on days one through five and venetoclax daily. Median follow-up period was 11.2 months.

在每个28天的治疗周期中，患者在第1至5天接受INQOVI治疗，并每日服用维奈托克。中位随访期为11.2个月。

The trial met its primary endpoint with a complete response (CR) rate of 46.5% (n=47).

该试验达到了其主要终点，完全缓解率（CR）为46.5%（n=47）。

In considering secondary endpoints, the study found that CR plus CR with incomplete hematologic recovery totaled 63.4% (n=64). Median overall survival was estimated to be 15.5 months. At 12 months, median duration of response had not been reached, and over 75% of patients achieving CR status remained in CR..

在考虑次要终点时，研究发现，完全缓解加上血液学恢复不完全的完全缓解总计达到63.4%（n=64）。估计的中位总生存期为15.5个月。在12个月时，尚未达到中位缓解持续时间，超过75%达到完全缓解状态的患者仍保持在完全缓解状态。

No new safety concerns were reported. Adverse events (AEs) of grade 3 and higher were reported in 98% of patients (n=99); most commonly, febrile neutropenia (49.5%), anemia (38.6%) and neutropenia (35.6%) were reported. No drug-drug interactions were observed between INQOVI and venetoclax.

未报告新的安全问题。98%的患者（n=99）报告了3级及以上的不良事件（AEs）；最常见的是发热性中性粒细胞减少症（49.5%）、贫血（38.6%）和中性粒细胞减少症（35.6%）。未观察到INQOVI与维奈托克之间存在药物相互作用。

At 30 and 60 days after the first dose of INQOVI, deaths attributed to either AEs or disease progression totaled 3% (n=3) and 9.9% (n=10) of study participants, respectively.

在首次服用INQOVI后30天和60天，因不良事件或疾病进展导致的死亡分别占研究参与者的3%（n=3）和9.9%（n=10）。

Results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2025 European Hematology Association (EHA) Congress.

结果在2025年美国临床肿瘤学会（ASCO）年会和2025年欧洲血液学协会（EHA）大会上公布。

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

AScertain-V研究：AStx727-07：地西他滨+CEdazuridine治疗AML，加用维奈托克

INDICATIONS

适应症

Decitabine and cedazuridine, marketed under the brand name INQOVI®, is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups..

地西他滨和塞达珠啶（商品名：INQOVI®）适用于治疗成年骨髓增生异常综合征（MDS）患者，包括先前接受过治疗和未接受治疗的、原发性和继发性MDS，涵盖以下法美英（FAB）亚型（难治性贫血、环形铁粒幼细胞性难治性贫血、过多原始细胞的难治性贫血以及慢性粒单核细胞白血病[CMML]），以及中危-1、中危-2和高危国际预后评分系统组别的患者。

INQOVI is the first and only oral hypomethylating agent approved by the FDA for the treatment of adults with intermediate and high-risk MDS including CMML.

INQOVI是首个也是唯一一个获FDA批准用于治疗中高危MDS（包括CMML）成年患者的口服低甲基化剂。

Commercialization of INQOVI in the U.S. is conducted by Taiho Oncology, Inc.

美国INQOVI的商业化由大鹏制药公司进行。

About Decitabine and Cedazuridine Fixed-Dose Combination

关于地西他滨和西达唑啶固定剂量组合

This product is an orally administered, fixed dose combination of the approved anti-cancer DNA hypomethylating agent, decitabine, together with cedazuridine,

该产品是一种口服的、固定剂量组合，包含已批准的抗癌DNA低甲基化剂地西他滨和赛达祖啶。

an inhibitor of cytidine deaminase.

胞苷脱氨酶的抑制剂。

By inhibiting cytidine deaminase in the gut and the liver, the fixed dose combination is designed to allow for oral delivery of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine administered over five days.

通过抑制肠道和肝脏中的胞苷脱氨酶，这种固定剂量组合旨在实现一个周期内连续五天口服地西他滨，以达到与静脉注射地西他滨五天相当的全身暴露水平。

About Taiho Oncology, Inc.

关于Taiho Oncology公司

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, Inc. 的使命是改善癌症患者、他们的家人及护理人员的生活。公司专注于开发和商业化用于各种肿瘤类型的口服抗癌药物。Taiho Oncology 拥有针对实体瘤和血液恶性肿瘤的丰富的小分子临床候选药物管线，同时还有其他处于临床前开发阶段的候选药物。