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Table 1 Supporting data for FDA approval of tisagenlecleucel for r/r B-ALL (≤ 25 years)

From: Chimeric antigen receptor (CAR) T therapies for the treatment of hematologic malignancies: clinical perspective and significance

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
  1. *Adapted from 10, 17. Abbreviations: OS Overall survival, CI Confidence interval, Mos Months, EFS Event-free survival