Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial
Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial
In recent years, an increasing number of anticancer drugs have been approved based on the results of a single-arm trial (SAT). The magnitude of the objective response rate (ORR) in SATs is important for regulatory decisions, but there has been no clear guidance specifying the degree of ORR for approval.