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Healthcare Economist February 21, 2023
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 indication. Response rate...
