EC approves Roche's Xeloda for colon cancer

Roche has announced that Xeloda (capecitabine) in combination with oxaliplatin (a combination known as XELOX) has been approved by the European Commission for the adjuvant (post-surgery) treatment of patients with early colon cancer.

The approval is based on data from a randomised, phase III, study of XELOX (oral Xeloda in combination with intravenous oxaliplatin) versus 5-FU/LV (a chemotherapy regimen) as adjuvant therapy for patients with stage III colon cancer who have undergone surgery. The study was carried out across 226 sites in 29 countries and involved 1,886 patients.

The primary objective of the study was to measure the superiority of XELOX in terms of the three-year disease-free survival (DFS) rate. XELOX was found to be superior to 5-FU/LV in 71.0 per cent of cases compared with 67.0 per cent.

"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.

Xeloda is already approved as a post-surgery monotherapy in patients with colon cancer throughout the world including Europe, the US and Japan. The drug is also approved in various countries for other indications including metastatic colorectal cancer, advanced gastric cancer, and metastatic breast cancer.

Professor Hans-Joachim Schmoll, from the Martin Luther University Clinic for Internal Medicine IV, in Halle, Germany and one of the lead investigators said: "I am delighted that XELOX will now be made available to patients with early colon cancer, particularly as it is at this stage of the disease that we have the best chance of curing them."

"Having a range of treatment options means more patients are given the chance to live without their disease returning, potentially enabling them to be cured," he added.

Colorectal cancer is the second most common cause of death from cancer across all tumour types in Europe and is the third most commonly reported cancer in the world.