抗体药物偶联物非临床安全性评价的考量因素
Considerations for the Nonclinical Safety Evaluation of Antibody-Drug Conjugates.
作者信息
Fisher J Edward
机构信息
Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, MD 20993, USA.
出版信息
Antibodies (Basel). 2021 Apr 19;10(2):15. doi: 10.3390/antib10020015.
Abstract
The targeted delivery of drugs by means of linking them to antibodies (Abs) to form antibody-drug conjugates (ADCs) has become an important approach in oncology and could potentially be used in other therapeutic areas. Targeted therapy is aimed at improving clinical efficacy while minimizing adverse reactions. The nonclinical safety assessment of ADCs presents several unique challenges involving the need to examine a complex molecule, each component of which can contribute to the effects observed, in appropriate animal models. Some considerations for the nonclinical safety evaluation of ADCs based on a literature review of ADCs in clinical development (currently or previously) are discussed.
摘要
通过将药物与抗体（Abs）连接以形成抗体-药物偶联物（ADCs）来实现药物的靶向递送，已成为肿瘤学领域的一种重要方法，并且有可能应用于其他治疗领域。靶向治疗旨在提高临床疗效，同时将不良反应降至最低。ADCs的非临床安全性评估面临若干独特挑战，包括需要在合适的动物模型中研究一种复杂分子，其每个组分都可能对观察到的效应有贡献。本文基于对处于临床开发阶段（当前或先前）的ADCs的文献综述，讨论了ADCs非临床安全性评估的一些考量因素。
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