The European Medicines Agency informed Roche that the filing for a new indication in Europe for the oral cancer drug Xeloda (capecitabine) in combination with another chemotherapy (cisplatin) for the treatment of patients with advanced gastric (stomach) cancer has been accepted. Stomach cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide.

The filing is based on results from the first-ever phase III study investigating the efficacy and safety of Xeloda/cisplatin compared to the current standard therapy of infusional 5-fluorouracil (5-FU) plus cisplatin as first-line treatment of the disease.

The study results confirmed that patients receiving the Xeloda/cisplatin combination therapy lived at least as long without the cancer progressing as those treated with the current standard therapy. Furthermore, for the first time in any cancer, Xeloda/cisplatin response rate (percentage of patients whose cancer shrinks after treatment) was superior, when compared to infusional 5-FU. Xeloda greatly simplifies the treatment regimen due to its oral form, reducing the need for hospital visits and allowing patients more precious time to spend with family and friends.

"Today marks a significant milestone for Roche. We are setting in motion the necessary steps to make this new and effective treatment available for European patients fighting advanced stomach cancer - a particularly painful and debilitating form of cancer," said Eduard Holdener, Head of Roche Pharmaceuticals Development.

"These new robust data are very encouraging - for the first time a viable alternative to the current standard intravenous treatment will become available for stomach cancer patients in Europe," stated lead investigator Prof. Y K Kang of the Asan Medical Center, Seoul, South Korea.

In Europe alone, nearly 140,000 people die from stomach cancer each year. Stomach cancer affects twice as many men as women and occurs more frequently in people aged over 55 years. Amongst tumours of the upper gastrointestinal tract, oesophagogastric cancer is more common in the West, whilst stomach cancer is predominant in the East.

The study, conducted by Prof. Kang and his team, is a large international phase III study in advanced stomach cancer. Some key highlights from this remarkable study, 'Randomised phase III trial of capecitabine/cisplatin vs. continuous infusion of 5-FU/cisplatin as first-line therapy in patients with advanced gastric cancer: efficacy and safety results' include:

o This phase III study was conducted in 316 advanced gastric cancer patients who were enrolled in 46 centres across 13 countries in Asia, South America, and Eastern Europe.

o The study compared the efficacy and safety of the Xeloda plus cisplatin combination (XP) with the intravenous 5-FU plus cisplatin combination (FP); FP is a standard treatment for gastric cancer, and accepted by regulatory agencies as the reference regimen against which all other regimens should be compared.

o The primary endpoint was non-inferiority in progression-free survival; patients receiving the XP combination therapy lived at least as long without the cancer progressing as those treated with FP (median progression-free survival 5.6 vs. 5 months, HR= 0.81, p=<0.001, demonstrating non-inferiority),

o The level of toxicity was similar between the two treatment arms. Gastrointestinal adverse events were among the most frequent adverse events in both treatment groups with nausea and vomiting being the most predominant adverse events.

o XP patients also lived at least as long overall (10.5 vs. 9.3 months, HR=0.85, p=0.008, demonstrating non-inferiority).

o XP response rate based on investigator assessment was superior to FP - this is the first time that Xeloda has shown superiority to infusional 5-FU rather than bolus 5-FU (overall response rate 41 vs. 29 per cent, p=0.030).

o XP reduces the amount of time a patient needs to visit the clinic by 80 per cent compared to FP (1 day vs. 5 days per 3 weeks).

Xeloda is licensed in more than 90 countries worldwide including the EU, USA, Japan, Australia and Canada and has been shown to be effective, safe, simple and convenient oral chemotherapy in treating over 1 million patients to date.

Roche received marketing authorisation for Xeloda as a first-line monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has spread to other parts of the body) in most countries (including the EU and USA) in 2001. Xeloda has also been approved by the European Medicines Agency (EMEA) and US Food and Drug Administration (FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June 2005, respectively.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.) 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. Xeloda is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.

The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome.