Roche confirmed European approval of Xeloda (capecitabine) as combination therapy with oxaliplatin for the post-surgical treatment of patients with early colon cancer. Approval is based on results from the pivotal NO16968 trial. Label extensions covering the Xeloada-oxaliplatin combination (commonly known as XELOX), are also expected in other territories Roche stated. Xeloda monotherapy is already approved in Europe, the U.S. and Japan and elsewhere, for the immediate post-surgical treatment of colon cancer patients.
First licensed in 2001, Xeloda is now available in over 100 countries as either monotherapy or combination therapy for the treatment of colorectal cancer, gastric cancer, and metastatic breast cancer.
The drug made sales of CHF1.26 billion ($1.18 billion) in 2009, up 7% on sales in 2008.