Roche announced that the European authorities have approved Xeloda (capecitabine), an innovative oral chemotherapy, to be used as an adjuvant treatment (post-surgery) for colon cancer. Patients will now have the choice of an effective, convenient chemotherapy that prolongs cancer free life, with a less serious side effect profile compared to the current standard treatment of intravenous 5-fluorouracil/leucovorin (i.v. 5-FU/LV).

Adjuvant chemotherapy is the standard treatment approach for stage III colon cancer where chemotherapy is given in order to destroy any cancerous cells remaining in the body after the tumour has been surgically removed.

"The European approval for Xeloda's new indication, again confirms Roche's commitment to providing innovative solutions for patients, whilst providing medical resource cost savings for today's healthcare providers" said William M Burns, CEO of Roche's Pharmaceutical Division. "For the first time colon cancer patients will have access to a unique treatment option that provides an effective oral therapy which is well-tolerated and can be taken at home."

"As the European approval decision was based on the landmark X-ACT trial, which showed that Xeloda should replace standard intravenous chemotherapy 5FU/LV, physicians and patients can be fully confident that they are using a very effective, safe and convenient treatment that is now available," said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow in Scotland.

The landmark X-ACT (Xeloda in Adjuvant Colon Cancer Therapy) trial which successfully met its primary endpoint, demonstrated that Xeloda is at least as effective compared to intravenous 5-FU/LV in terms of disease-free survival with a superior reduction in the risk of cancer recurrence (relapse-free survival).

In addition, on average, a patient only needed 8 hospital visits when treated with Xeloda compared to 30 visits if treated with i.v. 5-FU/LV.2 This results in significant cost savings, an important advantage for doctors, nurses and pharmacists in today's healthcare environment.

In 2004 approximately 88,000 patients in Europe who had advanced colorectal or breast cancer benefited from Xeloda. Based on the new indication approximately 55,000 colon cancer patients a year can now also be treated with this effective and convenient oral cancer treatment. Global sales in 2004 were 534 million Swiss francs and are expected to accelerate in 2005.