Roche receives extended US approval for Xeloda

Adjuvant chemotherapy is the standard treatment approach for Dukes’ C colon cancer (cancer that has spread to the lymph nodes), where chemotherapy is given after the tumor has been surgically removed. Approval of Xeloda (capecitabine) will now give patients who have undergone complete resection of their primary tumor the option of an oral chemotherapy when fluoropyrimidine therapy alone is preferred.

The adjuvant indication was based on data from a trial of Xeloda in adjuvant colon cancer. This pivotal trial showed that Xeloda met its primary endpoint of non-inferiority to 5-FU/LV for disease-free survival (DFS). 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.

Although intravenous 5-FU/LV has been the foundation of such treatment for 40 years, researchers have long recognized the need for more convenient treatment regimens. The 5-FU/LV intravenous regimen for colon cancer can require up to 30 clinic visits over the 24-week treatment course, compared to a minimum of eight visits for patients receiving Xeloda.

Xeloda is a drug taken orally which is activated into a chemotherapy agent by a naturally-occurring enzyme called thymidine phosphorylase, or TP. Once in contact with TP, which is expressed at higher levels by colorectal cancers, Xeloda is transformed inside the tumor into 5-FU, an anti-cancer drug.

Roche has an ongoing study program looking at Xeloda in combination with other chemotherapies and targeted therapies.