Sanofi-Synthelabo, a member of the sanofi-aventis Group announced that the US FDA has approved Eloxatin, in combination with conventional chemotherapy (infusional 5-fluorouracil/leucovorin, known as 5-FU/LV), for the adjuvant (postsurgical) treatment of patients with stage III colon cancer who have undergone complete resection of the primary tumour.

This is the first new chemotherapy approval for the adjuvant treatment of colon cancer in over a decade, offering patients new hope for potential cure of this disease, one of the nation's deadliest forms of cancer, the company said.

"The FDA approval of Eloxatin in this setting provides colon cancer patients with access to a potentially lifesaving treatment," said John L. Marshall, associate professor of Medicine, director of Development Therapeutics and GI Oncology for the Lombardi Cancer Centre at Georgetown University. "Early postsurgical treatment with this Eloxatin-based regimen offers patients the greatest opportunity of living longer without recurrence of their disease. This approval marks the beginning of a promising new era of benefit for patients with colon cancer," he added.

The FDA based its decision on results from the MOSAIC study, a large, international, randomized Phase III trial involving 2,246 patients in 146 centres. The results demonstrated that the addition of Eloxatin (oxaliplatin for injection) to conventional adjuvant chemotherapy for colon cancer (5-FU/LV) reduced the risk of recurrence of cancer by 24 per cent in the overall patient population who had undergone surgery to remove their primary tumour.

Kevin Lewis, co-founder and Chairman of the Colon Cancer Alliance said, "It's exciting that the FDA has made another option available to patients following surgery, particularly since early screening is increasing the number of people being diagnosed before the cancer has spread. This could offer a potentially lifesaving option to thousands of patients."

In the United States, Eloxatin received approval on January 9, 2004, for the first-line treatment of advanced carcinoma of the colon or rectum (ie, first therapy for patients with metastatic colorectal cancer). This approval is for the use of Eloxatin, in combination with infusional 5-FU/LV, for the treatment of advanced carcinoma of the colon or rectum.