Vorasidenib:首次批准。

IF 13 1区 医学 Q1 PHARMACOLOGY & PHARMACY
Drugs Pub Date : 2024-10-01 Epub Date: 2024-10-08 DOI:10.1007/s40265-024-02097-2
Yvette N Lamb
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引用次数: 0

摘要

Vorasidenib(VORANIGO®;Servier)是一种口服的、一流的、高度脑穿透性的突变型异柠檬酸脱氢酶1和2(IDH1/2)酶双重抑制剂,目前正在开发用于治疗IDH突变型弥漫性胶质瘤。Vorasidenib 于 2024 年 8 月 6 日在美国首次获得批准,用于治疗 12 岁及以上患有 2 级星形细胞瘤或少突胶质细胞瘤且在手术(包括活检、次全切除或全切)后出现易感 IDH1 或 IDH2 突变的成人和儿童患者。Vorasidenib获批的依据是跨国III期INDIGO试验的结果,在该试验中,相对于安慰剂,vorasidenib能显著改善无进展生存期和接受下一次抗癌干预的时间。目前,欧盟和全球其他国家正在对vorasidenib治疗IDH突变胶质瘤进行监管审查。本文总结了vorasidenib开发过程中的里程碑事件,这些事件促成了vorasidenib在胶质瘤领域的首次获批。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Vorasidenib: First Approval.

Vorasidenib (VORANIGO®; Servier) is an orally administered, first-in-class, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes being developed for use in IDH-mutant diffuse glioma. Vorasidenib received its first approval on 6 August 2024, in the USA, for the treatment of adult and pediatric patients aged 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery, including biopsy, sub-total resection, or gross total resection. Approval was based on results from the multinational phase III INDIGO trial, in which vorasidenib significantly improved progression-free survival and time to the next anticancer intervention relative to placebo. In the EU and other countries worldwide, regulatory review of vorasidenib in IDH-mutant glioma is currently underway. This article summarizes the milestones in the development of vorasidenib leading to this first approval for glioma.

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来源期刊
Drugs
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.
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