2023年FDA批准的癌症治疗药物进展

Development on Cancer Therapeutic Drugs Approved by FDA in 2023

自21世纪初以来,癌症药物开发领域发生了巨大的变化,激酶抑制剂是批准药物数量和适应证最多的产品类别;尽管2011年免疫检查点抑制剂才进入市场,但已经成为批准数量第二的产品类别。刚刚过去的2023年,美国FDA的药品评审与研究中心(CDER)批准了13种新的癌症治疗药物。近5年来,针对生物标志物定义人群的药物批准数量略有增加,同时出现了与肿瘤解剖部位无关的药物批准。目前,新治疗方法和新技术,如不断发展的AI技术,越来越深入影响着未来抗癌药物的开发。

Since the beginning of the 21st century,the field of cancer drug development has undergone significant changes.Kinase inhibitors are the product category with the highest number of approved drugs and indications.However,despite checkpoint inhibitors being only introduced to the market since 2011,they have become the second most approved product categories.In the year of 2023,the FDA’s Center for Drug Evaluation and Research(CDER)has approved 13 new cancer therapeutic drugs.In the past five years,a slight increase in drug approvals targeting biomarker-defined populations as well as emerging approvals that are agnostic to tumor anatomy has been recorded.Currently,new treatment approaches and technologies,such as the development of Artificial Intelligence(AI),have increasingly profound progress on cancer drug development.