Sanofi-Synthelabo announced that Eloxatin (oxaliplatin for injection), a new chemotherapy drug, has received approval following a 46-day priority review by the U.S. Food and Drug Administration (FDA). Eloxatin in combination with infusional 5-FU/LV was approved for an unmet medical need in patients whose advanced colorectal cancer has recurred or progressed following bolus 5-FU/LV plus irinotecan therapy.

Eloxatin used in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV) is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first-line therapy with the combination of bolus 5-FU/LV and irinotecan. The approval of Eloxatin is based on the response rate and improved time to tumor progression observed in an ongoing trial. Data that demonstrate a clinical benefit, such as improvement of disease-related symptoms or increased survival are not yet available.

In the pivotal trial ELOXATIN in combination with infusional 5-FU/LV demonstrated a statistically significant response rate compared to infusional 5-FU/LV alone. The response rate was defined as a 30% or greater reduction in overall tumor size, maintained for 4 weeks or more. Additionally, interim data on the median time to when a patient's disease progressed showed an increase of 2 months with the Eloxatin combination compared to infusional 5-FU/LV alone.

According to the American Cancer Society, colorectal cancer is the second leading cause of malignancy-related death in the U.S., accounting for more than 10 to 15% of all cancer death. Annually, about 150,000 new cases of colorectal cancer are diagnosed in the U.S. and about one million worldwide. Over a lifetime, about one in 18 people develop colorectal cancer, and, each year, about 56,000 people die from it in the U.S.

Sanofi-Synthelabo has worked very closely with the FDA, the investigators and the patient advocacy groups in bringing Eloxatin to physicians and their patients. Sanofi-Synthelabo will make Eloxatin commercially available in the U.S. by the end of August.

Eloxatin is currently marketed by Sanofi-Synthelabo in more than 55 countries and it is undergoing extensive worldwide clinical development for new indications. Global sales of Eloxatin reached EUR 196 million in 2001. Oxaliplatin was developed in association with Debiopharm S.A.