Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
National Cancer Institute, Rockville, MD, USA.
Nat Rev Drug Discov. 2023 Aug;22(8):625-640. doi: 10.1038/s41573-023-00723-4. Epub 2023 Jun 21.
The cancer treatment landscape has changed dramatically since the turn of the century, resulting in substantial improvements in outcomes for patients. This Review summarizes trends in the approval of oncology therapeutic products by the United States Food and Drug Administration (FDA) from January 2000 to October 2022, based on a categorization of these products by their mechanism of action and primary target. Notably, the rate of oncology indication approvals has increased in this time, driven by approvals for targeted therapies, as has the rate of introduction of new therapeutic approaches. Kinase inhibitors are the dominant product class by number of approved products and indications, yet immune checkpoint inhibitors have the second most approvals despite not entering the market until 2011. Other trends include a slight increase in the share of approvals for biomarker-defined populations and the emergence of tumour-site-agnostic approvals. Finally, we consider the implications of the trends for the future of oncology therapeutic product development, including the impact of novel therapeutic approaches and technologies.
自本世纪初以来，癌症治疗领域发生了巨大变化，患者的治疗效果显著改善。本综述根据作用机制和主要靶点对 2000 年 1 月至 2022 年 10 月期间美国食品和药物管理局 (FDA) 批准的肿瘤治疗产品进行了分类，总结了这些产品的趋势。值得注意的是，在此期间，由于靶向治疗的批准，肿瘤适应证的批准率有所增加，新治疗方法的引入率也有所增加。激酶抑制剂是按批准产品和适应证数量划分的主导产品类别，但尽管免疫检查点抑制剂直到 2011 年才进入市场，其批准数量却位居第二。其他趋势包括生物标志物定义人群批准比例略有增加，以及出现肿瘤部位不可知的批准。最后，我们考虑了这些趋势对肿瘤治疗产品开发未来的影响，包括新型治疗方法和技术的影响。
