Roche's Xeloda Approved for Stomach Cancer in Europe

The European Commission has approved Xeloda in combination with platinum-based chemotherapy for first-line use in patients with advanced stomach cancer, Roche announced.

Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide, according to Roche.

This approval was based on two trials, ML17032 and REAL 2. Both trials showed that patients on the Xeloda-containing arms lived at least as long overall as those on the 5-FU arms. In fact, the REAL 2 study showed patients on one of the Xeloda-containing arms lived significantly longer than the reference 5-FU arm.

Xeloda on its own is already approved for treating other gastrointestinal cancers, including colorectal cancer that has spread and postsurgery colon cancer. Recently, Roche submitted an application in the U.S. for Xeloda as first- and second-line treatment (with or without Avastin) for advanced colorectal cancer. In addition, Roche is running a large Phase III program in early stage colon cancer, which includes Xeloda in combination with oxaliplatin, with or without Avastin.

Xeloda is also approved for use in combination with Taxotere for treating women with metastatic breast cancer whose disease has progressed following intravenous chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines.