학술논문

Trends in the approval of cancer therapies by the FDA in the twenty-first century
Document Type
Review Paper
Source
Nature Reviews Drug Discovery. 22(8):625-640
Subject
Language
English
ISSN
1474-1776
1474-1784
Abstract
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.
Cancer therapy has changed substantially since the beginning of the century, with advances including kinase inhibitors and immunotherapies resulting in substantial improvements in treatment outcomes. This Review summarizes trends in the approval of oncology therapeutic products by the FDA since 2000 and discusses the implications for the future of anticancer drug development.