U.S. Food and Drug Administration Center for Drug Evaluation and Research
FDA Oncology Tools Approval Summary for levamisole for Adjuvant treatment in combination with 5-fluorouracil after surgical resection in patients with Dukes' Stage C colon cancer.

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.
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