我国Ⅰ类抗肿瘤靶向药物剂量选择策略及现状分析
Strategy and current situation analysis for dose selection of novel anti-cancer drugs in China
朱仲玲 1余俊1
作者信息
- 1. 天津医科大学肿瘤医院国家药物临床试验机构办公室/国家恶性肿瘤临床医学研究中心/天津市恶性肿瘤临床医学研究中心/天津市肿瘤防治重点实验室,天津 300060
- 折叠
摘要
目的:描述和分析2018-2023 年国家药品监督管理局首次批准上市的国产Ⅰ类抗肿瘤靶向药物剂量发现和选择策略.方法:通过收集国家药品监督管理局药品审评中心公布的药品审评报告、药品说明书以及所有药品上市前研究数据,梳理国产Ⅰ类抗肿瘤靶向药物的剂量选择策略.结果:42 款国产Ⅰ类抗肿瘤靶向药物中仅10 款在Ⅰ期临床试验阶段确定了最大耐受剂量,32 款说明书用量低于最大耐受剂量(maximum tolerated dose,MTD)或最大给药剂量.除了Ⅰa期剂量递增临床研究外,所有药物在剂量探索阶段均开展了1 个或多个剂量的扩展研究.结论:MTD不再是大多数新型抗肿瘤靶向药物剂量选择的主要依据,最佳给药策略是基于临床药理学研究结果的综合评估.
Abstract
Objective:To describe and analyze the dose discovery and selection strategies for domestically produced class Ⅰ anti-tumor targeted new drugs approved by the National Medical Products Administration from 2018 to 2023.Methods:By collecting drug evaluation reports,drug instructions,and all pre-market studies of drugs released by the Drug Evaluation Center of the National Medical Products Administration,the dosage selection strategies for ClassⅠanti-tumor targeted new drugs were sorted out.Results:Among the 42 domestically produced ClassⅠanti-tumor targeted drugs,10 were identified the maximum tolerable dose in the phase I clinical trials and 32 drugs were approved at a dose lower than the maximum tolerable dose or maximum administration dose.One or more dose expansion studies were conducted for all drugs beyond the dose-escalation studies.Conclusion:MTD is no longer the main basis for dose selection of most targeted anticancer drugs.The optimal dosing strategy is based on a comprehensive evaluation of clinical pharmacology results.
关键词
抗肿瘤靶向药物/剂量选择/最大耐受剂量/最佳剂量Key words
targeted anticancer drug/dose selection/maximum tolerated dose/optimal dose引用本文复制引用
出版年
2024
NETL
NSTL
万方数据