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Xeloda approved for treatment of advanced bowel cancer


The European Commission has today approval oral chemotherapy drug Xeloda® (capecitabine), manufactured by Roche, for the treatment of advanced bowel cancer in combination with any chemotherapy in all lines of treatment.

This approval was based on the international phase III pivotal study NO16966 which demonstrated that replacing intravenous drug 5-fluorouracil (5-FU) with Xeloda tablets in combination therapy with oxaliplatin provides patients with a more flexible treatment option with less hospital treatment time, whilst continuing to deliver the same survival benefits and safety as the previous standard chemotherapy iv 5-FU.

The most commonly reported adverse events with the treatment include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia).

“Bowel cancer is a devastating disease. Although treatment options for patients have improved many treatments require continuous intravenous infusion of 5-FU which impacts profoundly on quality of life,” said Dr Tim Iveson, Consultant Oncologist, Southampton General Hospital.

“Recent studies have shown that almost all patients with advanced bowel cancer can benefit from Xeloda in combination with other chemotherapy drugs at any stage of their treatment.

“It is a highly effective oral chemotherapy that importantly reduces hospital treatment time compared to the old standard chemotherapy, allowing patients to live as normal a life as possible. Oral Xeloda can replace iv 5-FU in all colorectal cancer regimens, making cancer treatment regimens easier for patients.”

The NHS has estimated that approximately 13,000 patients with advanced bowel cancer are treated with first-line therapy, 7,000 of whom go on to receive second-line therapy. 50% of these patients are already being offered combination therapy. These patients should now be able to benefit from this latest treatment advance.

Until now, treatment for patients with advanced bowel cancer has often involved combination therapy (more than one drug or agent) including intravenous infusion of 5-FU administered via a portable infusion pump permanently attached to the patient.  Added to the physical and emotional impact of treatment with 5-FU, it is also a time-consuming regimen, involving frequent visits to hospital for a lengthy infusion process.

Approval of Xeloda for the first line treatment of patients with advanced bowel cancer, and in combination with any chemotherapy in all lines of treatment, will alleviate patients from this burden of treatment.

Roche in the UK

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