NDA 21-877 Nelarabine Errata Please replace Tables 19, 20, 28 and 29 in the FDA Briefing Document with the following Tables Table 1: Transplantation of Pediatric CR and CR* patients Stratum 01 650 mg/m2 Stratum 02 650 mg/m2 Number 10/15 4/9 % 67 44
Table 2: Remission duration of pediatric non-transplanted patients Stratum 01 Remission duration (weeks) 33.1 (sys) 9.1 (IT) 6.3 2.3 1.4+ Stratum 02 Remission duration (weeks) 42.1 (IT + sys) 9.3 6.1 3.6 3.3
Table 28: Transplantation of Adult CR and CR* patients 1 Prior Induction Regimen >2 Prior Induction Regimens Number 1/3 1/6 % 33 17
Table 29: Remission duration of adult non-transplanted patients Remission duration (weeks) 1 Prior Induction Regimen >2 Prior Induction Regimens 217 195+ 5 30 19 15 4