美國食品藥品監(jiān)督管理局（FDA）于2022年2月發(fā)布了“抗體偶聯(lián)藥物的考慮”供企業(yè)用的指導(dǎo)原則草案，旨在幫助企業(yè)和其他參與者開發(fā)細胞毒性小分子藥物（有效載荷）的抗體偶聯(lián)藥物（ADC）。該指導(dǎo)原則闡述了FDA目前對ADC臨床藥理學(xué)開發(fā)方案的建議，包括生物分析方法、給藥方案、劑量和暴露反應(yīng)分析、內(nèi)在因素、QTc評估、免疫原性和藥物-藥物相互作用。ADC主要用于治療腫瘤，又是當前國內(nèi)藥物研發(fā)的熱點。中國目前還沒有類似的指導(dǎo)原則，詳細介紹FDA的該指導(dǎo)原則，期望有助于國內(nèi)對這類新藥的研發(fā)與監(jiān)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FDA issued the Considerations for Antibody-Drug Conjugates Draft Guidance for Industry in February 2022.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.

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