| Generic Drug Name |
levamisole
|
| Trade Name |
Ergamisol
|
| Sponsor or Applicant |
Janssen Research Foundation
|
| Application Number |
020035
|
| Supplement Number |
000
|
| Supplement Type Code |
N
|
| Dosage Form |
tablet
|
| General Indication |
colon-rectum
|
| Line or type of therapy |
Adjuvant
|
| Specific Indication |
Adjuvant treatment in combination with 5-fluorouracil after surgical resection in patients with Dukes' Stage C colon cancer.
|
| Subpart H-Accelerated Approval? |
0
|
| Filing Date |
Nov 01 1989
|
| Advisory Committee Date |
Feb 01 1990
|
| Advisory Committee Recommendation |
approvable (stage C colon cancer) 9-0
|
|
|
|
| Approval Date |
Jun 18 1990
|
| Number of Studies Reviewed |
2
|
| Study Comments |
Two randomized controlled studies of patients with resected colon with an indicator of poor prognosis and no evidence of residual disease. Over 400 patients in the first study and over 1200 in the second were used for analysis of both efficacy and safety.
Five Phase 2 studies were submitted to support approval.
|
| Study Results |
In one clinical trial in which 408 Dukes' B and C colorectal cancer patients were studies, 262 Dukes' C patients were evaluated for a minimum follow-up of 5 years. A subset analysis of these Dukes' C patients showed the estimated reduction in death rate was 27% for LEV plus 5-FU (p=.11) and 28% for LEV alone (p=.11).
In a confirmatory study 929 Dukes' C colon cancer patients were evaluated for a minimum follow-up of 2 years. The estimated reduction in death rate was 35% for LEV plus 5-FU (p=.0004). The estimated reduction in recurrence rate was 38% for LEV plus 5-FU (p=.0002). The LEV alone group did not show advantage over no treatment in improving recurrence or survival rates.
|
| Study Details
(Click on NDA or Supplement Number to view details) |
NDA 020035 Supplement 000
|
| Follow Up Commitments |
4/11/90 letter for PK/PD studies.
|
