Navigating Recent Changes in Dosing Information: Dynamics of FDA-Approved Monoclonal Antibodies in Post-Marketing Realities

IF 3.1 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Nai Lee, Su-jin Rhee, Seong Min Koo, So Won Kim, Gyo Eun Lee, Yoon A Yie, Yun Kim
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Abstract

Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates. Among the 86 mAbs evaluated, 21% (n = 18) exhibited changes in dosing information for the initial indication, with a median time to modification of 37.5 months (range: 5–76 months). Furthermore, for mAbs with extended indications (n = 26), 19.2% (n = 5) underwent dosing changes in their first extensions, with a median time to adjustment of 31 months (range: 8–71 months). Key drivers for these adjustments included optimizing therapeutic efficacy, addressing safety concerns, accommodating special populations, and enhancing patient convenience. We also discuss the role of model-informed drug development, real-world evidence, and pharmacogenomics in refining mAb dosing strategies. These insights underscore the importance of ongoing monitoring and data integration in the post-marketing phase, providing a foundation for future precision medicine approaches in mAb therapy.

Abstract Image

导航剂量信息的最新变化:上市后现实中fda批准的单克隆抗体的动态。
单克隆抗体(mAbs)是治疗领域的重要组成部分,但随着新数据的出现,其剂量策略往往会在批准后发生变化。本综述评估了 2015 年 1 月至 2024 年 9 月期间 FDA 批准的 mAbs 上市后标签中剂量信息的变化,重点关注初始适应症和扩展适应症。我们对剂量修改进行了系统分析,并将其分为六个预定义的组别:剂量增加或减少、根据体重或年龄纳入新的患者人群、从基于体重的给药方式转变为固定给药方式,以及输注率的调整。在接受评估的 86 种 mAbs 中,21%(n = 18)的初始适应症剂量信息发生了变化,修改的中位时间为 37.5 个月(范围:5-76 个月)。此外,对于有扩展适应症的 mAbs(n = 26),19.2%(n = 5)在首次扩展时进行了剂量调整,调整的中位时间为 31 个月(范围:8-71 个月)。这些调整的主要原因包括优化疗效、解决安全性问题、适应特殊人群以及为患者提供更多便利。我们还讨论了以模型为依据的药物开发、真实世界证据和药物基因组学在完善 mAb 剂量策略中的作用。这些见解强调了上市后阶段持续监测和数据整合的重要性,为未来 mAb 治疗的精准医学方法奠定了基础。
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来源期刊
Cts-Clinical and Translational Science
Cts-Clinical and Translational Science 医学-医学:研究与实验
CiteScore
6.70
自引率
2.60%
发文量
234
审稿时长
6-12 weeks
期刊介绍: Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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