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Comparison of Applications Reviewed Under RTOR and RTOR Combined with Project Orbis Since the Launch of Project Orbis in 2019 to May 2021
| Total Applications | Median Approval Time (Range) | Mean Approval Time | |
|---|---|---|---|
| RTOR and Project ORBIS | 21 (5 NMEs)a | 4.5 Months (1.5, 8) | 4.4 Months |
| RTOR Alone | 10 (4 NMEs) | 5 Months (3, 16) | 6.5 Monthsb |
aAll received priority review except for nivolumab sBLA
b5.4 months if dostarlimab is removed from the calculation
