FDA“抗体偶联药物的考虑”供企业用的指导原则草案介绍

Introduction to FDA's Considerations for Antibody-Drug Conjugates Draft Guidance for Industry

美国食品药品监督管理局(FDA)于2022年2月发布了“抗体偶联药物的考虑”供企业用的指导原则草案,旨在帮助企业和其他参与者开发细胞毒性小分子药物(有效载荷)的抗体偶联药物(ADC)。该指导原则阐述了FDA目前对ADC临床药理学开发方案的建议,包括生物分析方法、给药方案、剂量和暴露反应分析、内在因素、QTc评估、免疫原性和药物-药物相互作用。ADC主要用于治疗肿瘤,又是当前国内药物研发的热点。中国目前还没有类似的指导原则,详细介绍FDA的该指导原则,期望有助于国内对这类新药的研发与监管。

FDA issued the Considerations for Antibody-Drug Conjugates Draft Guidance for Industry in February 2022.It aims to assist industry and other parties develop antibody-drug conjugates(ADCs)with a cytotoxic small molecule drug(payload).This guidance describes FDA's current recommendations for the development programs of clinical pharmacology of ADC,including bioanalytical methods,dosing strategies,dose-and exposure-response analysis,intrinsic factors,QTc assessments,immunogenicity,and drug-drug interactions.Thus far,ADCs are used primarily in oncology indications.At present,there is no similar guidance in China,and ADC is a hot spot in China's current drug development and is in its infancy.The FDA's guidance is described in detail.It is expected to contribute to the development and supervision of this kind of new drugs in China.