Roche files Xeloda in EU for stomach cancer

Roche has filed Xeloda with the European Medicines Agency as a treatment for stomach cancer, following successful phase III trials demonstrating the effectiveness of the drug.

The study compared a Xeloda/cisplatin combination therapy with a standard infusional 5-fluorourcil (5-FU)/cisplatin therapy. The patients undergoing the Xeloda treatment were found to survive at least as long as those using 5-FU, while demonstrating a greater response rate.

Furthermore, Roche claims that Xeloda “greatly simplifies” treatment because it is taken orally, reducing treatment time and the need for many hospital visits.

Eduard Holdener, head of Roche pharmaceuticals development, stated: “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.”

Professor YK Kang of the Asian Medical Centre in Seoul, South Korea, added: “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.”

Xeloda has already been approved as a treatment for metastatic colorectal cancer, as well as for use to treat colon cancer, post-surgery. In addition, the drug is used in combination with Sanofi-Aventis’ Taxotere for women with metastatic breast cancer.

According to CORE, a charity that fights gut and liver disease, some 12,000 Britons are diagnosed with stomach cancer each year, although it is becoming less common. Women tend to develop the disease more so than men and it is unusual for it to occur in people under 45 years of age.

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