Single Arm Trials for FDA Drug Approvals in Oncology
These are becoming increasingly common. Agrawal et al. (2022) use data between 2002-2021, and found that FDA approved: …176 new malignant hematology and oncology indications based on single-arm trials, including 116 accelerated approvals (AAs) and 60 traditional approvals. Overall, 87 approvals (49%) were for new molecular entities or original biologics and 89 (51%) were supplemental…