Swiss Roche Holding AG, announce that the European Medicines Agency (EMEA) approved a label expansion use of blockbuster cancer drug Xeloda (Capacitabine) in combination with Sanofi-Aventis SA, Eloxatin (Oxaliplatin) for the initial treatment of post-surgery patients with colon cancer.

Last February, the EMEA Committee on Human Medicinal Products (CHMP) recommended approval after Phase III pivotal study results, known as NO 16968 (XELODA) that showed patients treated with XELOX combination immediately after surgery, survived longer compared to those treated with chemotherapy 5-Fluoruracil/Leuvovorin (5-FU/LV) classic treatment.

The study enrolled 1,864 patients, in 226 centers in 29 countries, The primary endpoint was to reveal XELOX superiority compared to 5-FU/LV survival rate for three years.

The three year study showed that 71 percent of the XELOX´s patients achieved its objective along the 36 month duration period, compared the 67 percent of patients treated with 5-FU/LV. After four years, the XELOX group objective was achieved by 68.4 percent compared to 62.3 percent of the 5-FU/LV group. After five years percentages were 66 and 60 percent for both groups.

Xeloda as a monotherapy is globally approved to treat colon cancer patients after surgery.

Xeloda´s sales climbed up to 1.307 million dollars during 2009, being the ninth best selling Roche drug.

Colon cancer is the second common cause of death in Europe and third cause worldwide.