Sanofi-Synthélabo announced that it has submitted a supplemental New Drug Application (sNDA) in the United States and an extension of indication in Europe with France as Reference Member State for Eloxatin (oxaliplatin for injection) in the adjuvant treatment of colon cancer.

Adjuvant therapy is a treatment following surgery, with the goal of eradicating any remaining cancer cells, and increasing the cure rate. In fact, adjuvant therapy offers promise for not just extending patients lives, but helping to assure full recovery without recurrence of cancer.

"Few treatment options exist for colon cancer in adjuvant setting. The submission for Eloxatin in this indication will allow to extend patients benefit to early stages and therefore curable stages of the disease," said Professor Aymery de Gramont, Head of Oncology Division at Saint-Antoine Hospital, Paris. "The major reduction in disease recurrence obtained with Eloxatin in the adjuvant setting will significantly impact the treatment of early stages of the disease, especially the ones with lymph nodes involvement."

Efficacy results of the Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin (5-FU/LV), in the adjuvant treatment of colon cancer (MOSAIC) were presented at the 39th annual meeting of the American Society of Clinical Oncology (ASCO) in June 2003. This pivotal trial showed that the addition of Eloxatin to the current standard of post-operative (adjuvant) chemotherapy (5FU/LV) for colon cancer reduces the risk of recurrence by 23 per cent (p<0.01) at three years in patients who have undergone surgery for their primary tumour.

Eloxatin received marketing approval in France for the 2nd line treatment of metastatic colorectal cancer in April 1996, and as a 1st line treatment in April 1998. In July 1999, Eloxatin was approved for the 1st line treatment indication in major European countries, through a mutual recognition procedure, France being the Reference Member State.

Eloxatin successfully completed a Mutual Recognition Procedure in Europe in December 2003, which will allow the product to be indicated for the full indication: "Treatment of Metastatic Colorectal Cancer in combination with 5-fluorouracil and folinic acid" (i.e. 1st line and 2nd line treatment).

In the US, Eloxatin was approved on January 9, 2004, for the first line treatment of metastatic carcinoma of the colon or rectum, after an approval in August 2002 for second line treatment of patients. This new approval recommends now the use of Eloxatin, in combination with infusional 5FU/LV, for the treatment of advanced carcinoma of colon or rectum in US.

Eloxatin is currently marketed by Sanofi-Synthelabo in more than 60 countries for the treatment of metastatic colorectal cancer.