The Timing of Cancer Drug Approvals in the United States and Europe

The study by Lythgoe and colleagues 1 provides insights into regulatory processes for cancer drug approvals between the 2 largest medical regulators in the world-the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). 1 Over the past decade, the FDA approved oncology drugs twice as fast as the EMA, more often through accelerated pathways, and often prior to study publication. Of the 89 cancer medicines approved both in the United States and Europe between 2010 and 2019, the FDA approved 95% (85 of 89) before European market authorization.