ERRATA
for the FDA Review
of
BL STN 125011/0
Bexxar®
(
Tositumomab (Anti-B1) and I131-Tositumomab)Corixa Corporation
Page 5
Table titled "Summary of Efficacy Outcomes by Study"
Correction: Primary Efficacy Studies, Study RIT-II-004 (N=61)
Pages 32-33
Correct Subtitles
"Violation of Eligibility Criteria"
"Violations of Informed Consent"
"Violation of Thyroid Protection Protocol"
"Violation of Timing for Dose Assessment of Administration of
Therapeutic Dose"
Page 35
Correction: Time from diagnosis to entry (years)
Page 41
Correction in Table
Response Rate in Subset without Transformation (N=37)
Page 95
Corrected Table
|
Age (Years) Median Range |
59 (37, 80) |
58 (37, 80) |
|
Gender Male (% male) |
41 (58%) |
23 (58%) |
|
Median time from diagnosis to study entry (years) (range) |
6.2 (0.7, 27.8) |
5.0 (0.7, 27.8) |
|
Median time from diagnosis to transformation date (years) (range) |
1.8 (-0.3, 10.3) |
1.9 (0.02, 9.9) |
|
Median time from transformation to study entry (years) (range) |
3.4 (0, 24.5) |
3.3 (0, 24.5) |
|
Ann Arbor Stage at entry 1 2 3 4 |
1 (1%) 7 (10%) 17 (24%) 46 (65%) |
1 (2%) 1 (2%) 11 (28%) 27 (68%) |
|
Modified IPI Score 0-1 2 3 4-5 |
(n = 67) 9 (13%) 23 (34%) 23 (34% 12 (18%) |
(n = 38) 2 (5%) 14 (37%) 16 (42% 6 (16%) |
|
Number of prior chemotherapies Median IQ Range |
4 (3, 5) (1, 11) |
4 (3, 5) (1, 9) |
|
Maximum unidimensional lesion measurement (cm) 0 to <5 cm >5 to <10 cm > 10 cm |
24 (34%) 34 (48%) 13 (18%) |
12 (30%) 20 (50%) 8 (20%) |
|
Response to last chemotherapy Response (CR+CCR+PR) Complete Response (CR+CCR) |
35 (49%) 16 (23%) |
22 (55%) 10 (25%) |
|
Tumor grade at the study entry Low Intermediate High |
9 (13%) 59 (83%) 3 (4%) |
2 ( 5%) 35 (88%) 3 (8%) |
|
Last qualifying chemotherapy end day to study day (yrs) Median Range |
(n = 66) 0.5 (0.1, 5.4) |
(n = 35) 0.5 (0.1, 3.1) |