Analysis methodology
We used descriptive statistics to describe the dataset, which was divided in 3 time periods (2008–2012, 2013–2016, and 2017–2020) for subgroup summaries. Fisher exact test was used to compare the characteristics among the 3 time periods. Some approvals incorporated ongoing trials planned with adaptive designs at the time the products were approved. We performed additional descriptive statistics by study progressions (approved with ongoing study or completed study ) and compared the features using Fisher exact test. To detect a trend over time in the yearly numbers of approvals, we performed joinpoint regression analyses via the Joinpoint Regression Program version 4.7.0.0 (National Cancer Institute and Information Management Services Inc., Bethesda, MD, USA). Other statistical analyses were carried out using SAS version 9.4 (SAS Institute, Carey, NC, USA). Differences were considered significant based on 2-sided tests if P values were less than 0.05.