Table of Contents
Past FDA Approvals in Colorectal Cancer
Outline of Presentation
Agents Approved
Historical Endpoints for Approved Agents
Agents for Adjuvant Therapy
Levamisole (Adjuvant Rx)
Agents for First-line Therapy
5FU+leucovorin (First-line Rx)
Irinotecan (First-line Rx)
Capecitabine (First-line Rx)
Agents for Recurrent Cancer
Irinotecan (Recurrent) (accelerated approval)
Irinotecan (Recurrent) (full reg. approval)
Oxaliplatin (Recurrent) (accelerated approval)
NDAs Discussed at ODAC but not Approved
Basis of Approval
PPT Slide
PPT Slide
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Author: CDER User
Home Page: http://www.fda.gov/cder/drug/cancer_endpoints/default.htm
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