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Xeloda approved in Europe for the treatment of advanced stomach cancer


New effective oral treatment option also reduces time in hospital by 80%

The European Commission approved Xeloda in combination with platinum-based chemotherapy, for first-line use in patients with advanced stomach cancer. Oral chemotherapy Xeloda is already replacing standard intravenous (i.v.) therapy 5-fluorouracil (5-FU) in other gastrointestinal cancers, and now for the first time patients with advanced stomach cancer will also benefit from this effective and convenient treatment option.

William M. Burns, CEO Roche Pharma Division, said: “The news from the European Commission is welcome by both patients and physicians. Stomach cancer is a particularly aggressive and debilitating type of cancer and with Xeloda, Roche can provide an effective oral therapy resulting in a cost effective approach with less hospital visits and more flexibility for the patient”.

Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide1. Annually, there are an estimated 911,000 deaths worldwide2, with nearly 140,000 deaths in Europe alone3.

“Not only is capecitabine as effective and safe as intravenous treatment but it also reduces the time patients need to spend in hospital by 80%, from five days every three weeks to only one day every three weeks.” said Professor Y.K. Kang of the Asan Medical Center, Seoul, South Korea. “Up to now, the standard treatment has involved using intravenous pumps which the patients find inconvenient and uncomfortable. As an oral drug, capecitabine can be taken in the comfort of your own home, making it much more convenient. The clinical community welcomes this news as we now have a new option for our patients”

The approval of Xeloda in combination with platinum-based chemotherapy (with or without epirubicin), was based on two trials, called ML17032 and REAL 2. Both these 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 (EOX) lived significantly longer than the reference 5-FU arm (ECF).

Xeloda on its own is already available in other gastrointestinal cancers, including colorectal cancer that has spread and post-surgery colon cancer. Recently, Xeloda has been filed in the USA for first and second line treatment (with or without Avastin) of advanced colorectal cancer. Additional filings of Xeloda and Avastin combination therapy are planned in the near future. In addition, Roche is running a large Phase III program in early stage colon cancer, which includes Xeloda in combination with oxaliplatin (XELOX) with or without Avastin.


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