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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