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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

- FDA Approval Based on Updated Results Showing a 20% Reduction in the Risk of Death at Six Years and a 22% Improvement of Disease Free Survival at

Five Years, For Stage III Colon Cancer, Post Surgery -

BRIDGEWATER, N.J., May 28 /PRNewswire-FirstCall/ -- Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include six-year overall survival analysis from the MOSAIC trial in the Eloxatin(R) (oxaliplatin injection) prescribing information (PI). The new PI also reports five-year disease free survival (DFS) data in Stage III colon cancer patients treated following surgery to remove the primary tumor.

The MOSAIC trial results showed that after a median follow-up of six years, Stage III colon cancer patients treated with FOLFOX4 had a 20 percent reduction in the risk of dying compared to those treated with standard chemotherapy alone (hazard ratio of 0.80, confidence interval [0.65, 0.97] p=0.023). Stratified log-rank test was not adjusted for multiple comparisons. Also, Stage III patients treated with the Eloxatin-based regimen at 5 years were 22 percent less likely to relapse or risk of disease recurrence (HR=0.78 [CI: 0.65, 0.93], p =0.005) after 77 month follow-up.

"The MOSAIC six-year follow-up data demonstrate that as an adjuvant treatment for Stage III colon cancer, the Eloxatin-based regimen significantly lowered the risk of death and recurrence," said principal investigator Aimery de Gramont, MD, Oncology, Hospital Saint Antoine, Paris, France.

In the MOSAIC trial, neutropenia (decrease in the number of white blood cells) was the most frequently reported side effect, affecting 78.9% of patients. Neutropenia was complicated by fever or infection in only 1.8% of cases. Peripheral sensory neuropathy ("tingling or numbness" in the fingers or toes) occurred in 92.1% of patients treated with FOLFOX4. Half (48.2%) of the episodes were gra
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