Ifupinostat：首次批准。

IF 14.4 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-09-30 DOI:10.1007/s40265-025-02248-z

Simon Fung

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引用次数: 0

摘要

Ifupinostat （; Betlin）是BeBetter Med开发的首个双磷酸肌肽3-激酶α (PI3Kα)/组蛋白去乙酰化酶（HDAC）抑制剂，用于治疗复发或难治性弥漫性大b细胞淋巴瘤。2025年6月30日，伊夫匹诺他在中国首次获得批准，作为复发或难治性弥漫性大b细胞淋巴瘤成人患者的单药治疗，这些患者接受了至少两种全身治疗。继续批准取决于验证性、随机、对照3期试验的结果。这篇文章总结了伊夫匹诺他发展的里程碑，导致伊夫匹诺他首次被批准作为复发或难治性弥漫性大b细胞淋巴瘤成人患者的单药治疗，这些患者接受了至少两种全身治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Ifupinostat: First Approval.

Ifupinostat (; Betlin) is a first-in-class dual phosphoinositide 3-kinase α (PI3Kα)/histone deacetylase (HDAC) inhibitor being developed by BeBetter Med for the treatment of relapsed or refractory diffuse large B-cell lymphoma. On the 30th June 2025, ifupinostat received its first approval in China as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systemic therapy. Continued approval is dependent on the results of a confirmatory, randomized, controlled phase 3 trial. This article summarizes the milestones in the development of ifupinostat leading to this first approval as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systemic therapy.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.