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Surrogate-Based Approvals for Which Subsequent Trials Report an OS Benefit or a Lack of Survival Benefit or for Which No Trials Exist Showing or Refuting a Survival Benefit
| Indication | Approvals (No. [%]) | ||
|---|---|---|---|
| Proven OS benefit | No OS benefit | OS benefit unknown | |
| Total (n=55) | 10 (18.2) | 15 (27.3) | 30 (54.5) |
| Accelerated approval (n=25) | 6 (24.0) | 3 (12.0) | 16 (64.0) |
| Traditional approval (n=30) | 4 (13.3) | 12 (40.0) | 14 (46.7) |
OS =overall survival.
