ONCOLOGIC DRUGS ADVISORY COMMITTEE

March 16, 2000

Briefing Information

Oxaliplatin

FDA Medical Review, Preliminary Report to the Oncologic Drugs Advisory Committee on NDA 21063 Eloxatin (Oxaliplatin) for first line therapy for colorectal cancer, Clinical Considerations, Steven Hirschfeld, MD PhD, Fumitaka Nagamura, MD PhD, John R Johnson, MD

Statistical Review and Evaluation - Summary Statement, Stephen Hirschfeld, MD, Mark Rothmann, PhD

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Briefing Document of the Effectiveness and Safety of Oxaliplatin in Combination with 5-FU-Based Chemotherapy in the Treatment of Advanced Colorectal Cancer, Sanofi-Synthielabo Research

Irinotecan Hydrochloride (Camptosar InjectionÒ )

Medical Officer Summary Statement for the Advisory Committee, Irinotecan Hydrochloride (Camptosar InjectionÒ ) for Colorectal Cancer , (Application for Irinotecan as a Component of First-line Therapy of Patients with Metastatic Carcinoma of the Colon or Rectum) , Isagani M. Chico, MD

Summary Statement Statistical Review and Evaluation, Isagani Chico, MD, David Smith, PhD

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Irinoteca Hydrochloride (CPT-11, Camptosar) Oncologic Drugs Advisory Committee Brochure, NDA #20-571, Supplement #9 (First-Line Therapy of Colorectal Cancer), Pharmacia & Upjohn