Roche’s Xeloda (capecitabine) in combination with oxaliplatin (a combination known as XELOX) has been approved by the EMEA for the adjuvant treatment of patients with early colon cancer. The approval was based on results from the NO16968 (XELOXA) study in patients with stage III (early) colon cancer, which showed that patients taking XELOX after surgery lived disease free for longer compared to those treated with chemotherapy regimen 5-fluorouracil/leucovorin (5-FU/LV).

“The approval of XELOX for the adjuvant treatment of early colon cancer is great news for patients, who now have the added benefits and convenience of oral Xeloda in combination therapy for this disease, which is potentially curable if diagnosed and treated promptly,” said Pascal Soriot, chief operating officer, Roche Pharmaceutical Division.

Additional label extensions for XELOX in other regions of the world are also expected. Xeloda monotherapy is already approved for use immediately after surgery in patients with colon cancer throughout the world including Europe, the U.S. and Japan.