The European authorities have granted a positive opinion for Xeloda (capecitabine), an innovative oral chemotherapy, of Roche, to be used as an adjuvant treatment (post-surgery) for colon cancer. Full marketing approval for this new indication is anticipated within the next few months.

Adjuvant chemotherapy is one of the most common treatment approaches for colon cancer where chemotherapy is given in order to destroy any cancerous cells remaining in the body after the tumour has been surgically removed. Data from a major study (X-ACT) has shown that oral Xeloda is at least as effective and has a favourable toxicity profile to the intravenous chemotherapy commonly used to treat patients after surgery, but is more convenient as patients can take the therapy at home.

The CHMP positive opinion was granted based on the results of the landmark X-ACT trial. This clinical study successfully met its primary endpoint with Xeloda showing a strong trend towards reducing the risk of cancer recurrence.

"Xeloda should replace 5FU/LV in adjuvant treatment of colon cancer," Professor Jim Cassidy, one of the X-ACT study investigators said adding, "The landmark X-ACT trial clearly shows that Xeloda is not only an effective and patient-friendly regimen but also offers significant economic benefits as it does not require expensive and time-intensive hospital visits.