Switzerland’s Roche says that it has won the green light from the US Food and Drug Administration to market its oncology agent, Xeloda (capecitabine), for use following colon cancer surgery.

The drug is now specifically indicated for treating the Dukes’ C form of colon cancer that has spread to the lymph nodes, after the tumour has been surgically removed. Approval was based on data from the X-Act trial, in which Xeloda met its primary endpoint of non-inferiority to the standard chemotherapy regimen of intravenous 5-fluorouracil and leucovorin, for disease-free survival.

Xeloda is also approved in the treatment of both breast and advanced colorectal cancers and generated some 165 million Swiss francs in second quarter sales – up 48% on the previous year [[19/04/05b]]. Roche is has an ongoing study programme looking at Xeloda in combination with other chemotherapies and targeted therapies.

Colorectal cancer is the third leading cause of cancer-related deaths in the USA, and the second worldwide. The American Cancer Society estimates that in 2005, more than 145,000 Americans will be diagnosed with colorectal cancer and more than 56,000 will die from the disease.