2023 年美国 FDA 批准情况：生物标志物阳性子集、等效和效益验证

IF 81.1 1区医学 Q1 ONCOLOGY

Nature Reviews Clinical Oncology Pub Date : 2024-02-21 DOI:10.1038/s41571-024-00871-5

Kelly J. Norsworthy, Rosa J. Lee-Alonzo, Richard Pazdur

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引用次数: 0

摘要

2023 年，美国 FDA 批准了几种新的癌症药物和生物制剂，包括七种小分子抑制剂、四种双特异性 T 细胞诱导剂、两种抗 PD-1 抗体和一种细胞疗法产品。监管的重点领域包括对生物标志物阳性亚组的疗效分析、随机对照试验的等效性以及要求在加速审批前进行确证试验的新授权。

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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FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit

In 2023, the US FDA approved several new cancer drugs and biologic agents, including seven small-molecule inhibitors, four bispecific T cell engagers, two anti-PD-1 antibodies and one cell therapy product. Regulatory focus areas included analyses of biomarker-positive subgroups that drive efficacy, equipoise in randomized controlled trials and a new authority to require confirmatory trials be underway before accelerated approval.

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来源期刊

Nature Reviews Clinical Oncology 医学-肿瘤学

CiteScore

99.40

自引率

0.40%

发文量

114

审稿时长

6-12 weeks

期刊介绍： Nature Reviews publishes clinical content authored by internationally renowned clinical academics and researchers, catering to readers in the medical sciences at postgraduate levels and beyond. Although targeted at practicing doctors, researchers, and academics within specific specialties, the aim is to ensure accessibility for readers across various medical disciplines. The journal features in-depth Reviews offering authoritative and current information, contextualizing topics within the history and development of a field. Perspectives, News & Views articles, and the Research Highlights section provide topical discussions, opinions, and filtered primary research from diverse medical journals.