Roche announced that the US Food and Drug Administration (FDA) has approved Xeloda (capecitabine), an innovative oral chemotherapy, for the adjuvant (post-surgery) treatment of colon cancer patients.

Adjuvant chemotherapy is the standard treatment approach for Dukes’ C colon cancer (Stage III cancer that has spread to the lymph nodes), where chemotherapy is given after the tumour has been surgically removed. This approval will now give patients who have undergone complete resection of their primary tumour the option of an oral chemotherapy when treatment with fluoropyrimidine therapy alone is preferred. Xeloda as an oral fluoropyrimidine compares favourably with intravenous infusion requiring multiple hospital visits.

“Following European approval in March 2005 the FDA also supports Xeloda’s new indication. This again confirms Roche’s commitment to providing innovative solutions for patients, while providing medical resource cost savings for today’s healthcare providers”, said William M Burns, CEO Division Roche Pharma. “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.”

The FDA’s decision was based on the landmark X-ACT (Xeloda in Adjuvant Colon Cancer Therapy) trial. The trial successfully met its primary endpoint, showing Xeloda is non-inferior to 5-FU/LV for disease-free survival.

At this time, neither Xeloda nor combination chemotherapy has been shown to prolong overall survival; combination chemotherapy has demonstrated an improvement in disease free survival compared to 5-FU/LV.

On average, a patient only needed 8 hospital visits when treated with Xeloda compared to 30 visits if treated with i.v. 5-FU/LV2. This results in significant cost savings - an important advantage for doctors, nurses and pharmacists in today’s healthcare environment.

Roche has a large ongoing study programme looking at Xeloda in combination with other chemotherapies and targeted therapies in breast and colon cancer.

“More than 145,000 Americans will be diagnosed with colon cancer this year, so it’s important that the cancer community continually seeks to improve available treatment options,” said Carolyn Aldige, President of the Cancer Research and Prevention Foundation. “We commend Roche’s commitment, as evidenced by today’s FDA approval, to bringing effective and more convenient options to patients with colon cancer.”