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应对剂量信息的近期变化:上市后实际情况中FDA批准的单克隆抗体动态

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

作者信息

Lee Nai, Rhee Su-Jin, Koo Seong Min, Kim So Won, Lee Gyo Eun, Yie Yoon A, Kim Yun

机构信息

College of Pharmacy, Daegu Catholic University, Gyeongsan, Korea.

College of Pharmacy, Wonkwang University, Iksan, Korea.

出版信息

Clin Transl Sci. 2025 Jan;18(1):e70125. doi: 10.1111/cts.70125.

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.

摘要

单克隆抗体(mAb)是治疗领域的关键组成部分,但其给药策略通常会在获批后随着新数据的出现而演变。本综述评估了2015年1月至2024年9月美国食品药品监督管理局(FDA)批准的mAb在上市后给药信息的标签变更情况,重点关注初始适应症和扩展适应症。我们系统地分析了给药调整情况,将其分为六个预定义类别:剂量增加或减少、按体重或年龄纳入新的患者群体、从基于体重的给药方式转变为固定给药方案以及输注速率调整。在评估的86种mAb中,21%(n = 18)在初始适应症的给药信息上出现了变化,变更的中位时间为37.5个月(范围:5 - 76个月)。此外,对于有扩展适应症的mAb(n = 26),19.2%(n = 5)在首次扩展时进行了给药变更,调整的中位时间为31个月(范围:8 - 71个月)。这些调整的关键驱动因素包括优化治疗效果、解决安全问题、适应特殊人群以及提高患者便利性。我们还讨论了模型指导药物研发、真实世界证据和药物基因组学在优化mAb给药策略中的作用。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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3f6/11729449/d3ff36aeee25/CTS-18-e70125-g001.jpg

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