Wang Shuhang, Yang Qiuyan, Deng Lan, Lei Qi, Yang Yuqi, Ma Peiwen, Men Yuxin, Yung Bryant C, Lee Robert J, Zhang Mengzi, Li Ning
National Central Cancer Registry, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
The Whiteoak Group, Inc., Rockville, MD, USA.
Drug Discov Today. 2022 May;27(5):1236-1250. doi: 10.1016/j.drudis.2021.12.021. Epub 2021 Dec 29.
The use of expedited approval pathways for anticancer drug development, which provide the advantages of high efficiency and cost-effectiveness, has expanded significantly in recent years. During the past decade, a total of 410 new molecular entities have been approved by the US Food and Drug Administration (FDA), with a steady growth of 6.5% in the US. In Europe, 9-75% of approved anticancer drugs were granted at least one expedited approval program. Various expedited pathways have also been implemented worldwide to address underrepresented medical needs rapidly. China has adapted several expedited approval programs, including breakthrough therapy designation, priority review, and conditional approval, to keep up with the growth in pharmaceutical development. It is expected that worldwide standards for drug approval will become more standardized in the next decade.
用于抗癌药物研发的加速审批途径具有高效和成本效益的优势,近年来已显著扩展。在过去十年中,美国食品药品监督管理局(FDA)共批准了410种新分子实体,在美国以6.5%的稳定增长率增长。在欧洲,9%至75%的获批抗癌药物至少获得了一项加速审批计划。全球各地也实施了各种加速途径,以迅速满足未得到充分满足的医疗需求。中国采用了多种加速审批计划,包括突破性疗法认定、优先审评和附条件批准,以跟上药物研发的增长步伐。预计在未来十年,全球药物审批标准将变得更加规范。