Strategy and current situation analysis for dose selection of novel anti-cancer drugs in China
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.
NETL
NSTL
万方数据
