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New Eloxatin(R) (oxaliplatin injection) Prescribing Information in the U.S. Includes Six-Year Overall Survival Data
Date:5/27/2008

de 1, and 12% were severe (grades 3 and 4). Partial or total recovery was observed within 18 months following treatment in most patients experiencing grade 3 peripheral sensory neuropathy. Patients treated with FOLFOX4 also reported nausea (73.7%), diarrhea (56.3%) and vomiting (47.2%).

"This announcement is welcome news for patients who have a significantly higher chance of surviving Stage III colon cancer when treated with the Eloxatin-based regimen following surgery," noted Dr. de Gramont. "Inclusion of these survival results in the new U.S. Eloxatin PI marks an important milestone in the treatment of colon cancer."

About MOSAIC

Eloxatin(R) in combination with infusional 5-FU/LV was first granted U.S. approval in 2004 for the treatment of Stage III colon cancer patients who have their primary tumors surgically removed based on the disease-free survival data from MOSAIC after a median follow-up of three years. At the time of the original analysis, there was no demonstrated benefit in overall survival after a median follow-up of four years.

Supported by sanofi-aventis, the phase III controlled MOSAIC trial was conducted in 148 centers in 20 countries. In MOSAIC, 2,246 patients with Stage II or Stage III colon cancer whose tumor had been completely surgically removed were randomized to treatment with either the Eloxatin-based FOLFOX4 regimen (n=1,123) or standard chemotherapy 5-FU/LV (n=1,123) every two weeks for 12 cycles. The primary endpoint evaluated how the addition of Eloxatin affected disease-free survival at three years. Secondary endpoints included overall survival and safety, including long-term adverse effects.

About Colorectal Cancer

Stage II colorectal cancer indicates that the cancer has grown through the wall of the colon or rectum but has not yet spread to nearby lymph nodes. At Stage III, the cancer has invaded one or more of the local lymph nodes but has not spread to distant sites. Metastatic colorectal ca
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SOURCE sanofi-aventis
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