Table 1 Supporting data for FDA approval of tisagenlecleucel for r/r B-ALL (≤ 25 years)
Drug | Tisagenlecleucel |
Indication | r/r B-ALL (≤ 25 years) |
Clinical Trial | ELIANA (NCT02228096) |
Overall Survival (N) | 75 |
12-month OS (%) | 76 |
95% CI | (63–86) |
Median OS (mos) | 19.1 |
95% CI | (15.2 – NE) |
Event-free Survival (N) | 73 |
12-month EFS (%) | 50 |
95% CI | (35–64) |
Duration of Remission (N) | 61 |
Median (mos) | NR |