Roche eyes expanded colon cancer label for Xeloda
pharmafile | July 20, 2009 | News story | Research and Development, Sales and Marketing |Â Â Roche, XelodaÂ
Roche is set to expand Xeloda's colon cancer indication, after a new combination of the drug was shown to increase the time patients live disease-free following surgery compared with a common chemotherapy combination.
Xeloda is already approved for the treatment of early-stage colon cancer as monotherapy, Roche said the licence it is seeking would give patients more treatment options.
The company is already a world leader in oncology, and with the move looks to increase its position in the market by replacing established standard treatments with its own products.
William Burns, chief executive of Roche's pharmaceuticals division, said: "This is an important development for patients as colon cancer, if caught early enough, can be cured, so physicians need a wide range of treatment options."
Colorectal cancer is the second most common cause of death from cancer across all cancer types in men and women in Europe, and is the third most commonly reported cancer in the world, with nearly one million cases occurring annually.
Xeloda is an oral chemotherapy drug that can be used alone, or in combination with other drugs, currently for the treatment of colorectal (including colon), stomach and breast cancer.
It has a major advantage in its pill form, as opposed to traditional hospital-administered chemotherapy, meaning patients require fewer hospital visits.
Roche plans to file the data with health authorities to expand the drug’s label after results from the phase III study NO16968, which investigated oral Xeloda in combination with intravenous oxaliplatin (Sanofi-Aventis' off-patent Eloxatin) immediately after surgery.
It found that patients with colon cancer taking Xeloda in combination with intravenous oxaliplatin live disease-free for longer compared to those taking the commonly used intravenous chemotherapy combination 5-fluorouracil/leucovorin (5-FU/LV).
Roche's pharmaceuticals division is the world leader in anti-cancer medicines, with a portfolio that includes Avastin, Herceptin and Rituxin.
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