2022 年 FDA 肿瘤学批准的重点：组织非特异性适应症、剂量优化和药物开发中的多样性。
Highlights of FDA Oncology Approvals in 2022: Tissue-Agnostic Indications, Dosage Optimization, and Diversity in Drug Development.
机构信息
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
出版信息
Cancer Discov. 2022 Dec 2;12(12):2739-2746. doi: 10.1158/2159-8290.CD-22-1185.
In 2022, cancer drug development continued to progress rapidly despite the lingering COVID-19 pandemic. Highlights of U.S. drug approvals for oncology indications this year include ongoing development in rare diseases and molecular subgroups, improved dosage optimization, and updated data for drugs granted accelerated approval, with confirmatory studies demonstrating verification of clinical benefit in some instances, as well as indication withdrawal when clinical benefit was not verified.
2022 年，尽管 COVID-19 大流行仍在持续，但癌症药物的开发仍在迅速推进。今年美国肿瘤药物批准的亮点包括罕见病和分子亚群的持续开发、优化剂量、加速批准药物的更新数据，在某些情况下，确证研究证实了临床获益，而在未证实临床获益的情况下则撤回了适应证。
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