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Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Priority Review
Date:2/20/2008

- Review Based on MOSAIC Clinical Trial Demonstrating Significantly Improved Six-year Overall Survival in Stage III Colon Cancer Following

Surgery Compared to Standard Regimen Alone -

BRIDGEWATER, N.J., Feb. 20 /PRNewswire-FirstCall/ -- Sanofi-aventis today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and assigned priority review status to a supplemental new drug application (sNDA) that proposes changes to the Eloxatin(R) (oxaliplatin injection) prescribing information (PI) to include a six-year analysis from the MOSAIC trial. In the proposed PI changes, sanofi-aventis is seeking the inclusion of six-year overall survival and five-year disease free survival data in Stage III colon cancer patients treated with either FOLFOX4 (Eloxatin- based chemotherapy regimen) or standard infusional 5-FU/LV-based chemotherapy alone, following surgery to remove the primary tumor.

A priority review designation sets the target date for the completion of the FDA's review of the proposed changes at or before six months from the date of filing.

"We are pleased that FDA is giving priority review to our application for a label change to include updated six-year overall survival data," said Dr. Nassir Habboubi, Vice President of U.S. Medical Affairs, Oncology, for sanofi- aventis. "Inclusion of these data in the prescribing information would provide physicians with a more updated analysis than the existing PI and will help them better evaluate the use of prescribing an Eloxatin(R)-based chemotherapy regimen for their Stage III colon cancer patients."

In the MOSAIC trial, Stage III colon cancer patients treated after complete surgical resection of the tumor with Eloxatin in combination with infusional 5-FU/LV had a significant reduction (20%) in the risk of dying after a median of six years compared to standard 5FU/LV-based chemotherapy alone (hazard ratio of 0.80, confidence interval [0.65, 0.97],
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