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EU gives Xeloda broader approval

The European Commission has approved Roche's oral chemotherapy drug Xeloda for the treatment of metastic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin.

The European Commission has approved Roche's oral chemotherapy drug Xeloda for the treatment of metastic colorectal cancer in combination with any chemotherapy in all lines of treatment with or without Avastin.

This broad approval allows more patients suffering from colorectal cancer that has spread to have more, patient-friendly treatment options.

According to pivotal studies, Xeloda tablets provide a more flexible treatment option for patients, involving less hospital time but the same survival benefits and safety as the previous standard chemotherapy intravenous (iv) 5-FU.

The studies also showed that Avastin in combination with chemotherapy allows patients to live significantly longer without their cancer progressing.

"The previous standard treatment, iv 5-FU was particularly burdensome on patients," said Roche in a statement.

"Now oral Xeloda offers a better alternative that can be used alone or in combination with oxaliplatin or irinotecan to provide a therapy that is highly effective, safe and flexible," Roche concluded.

"Colorectal cancer is a devastating disease and treatment options for patients have been limited," said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre, at the University of Glasgow, Scotland.

"Until now, Xeloda has been available to only a few colorectal cancer patients. But several studies have now shown that almost all patients with colorectal cancer that has spread can benefit from Xeloda at any time and in combination with any chemotherapy treatment.  It is a highly effective oral chemotherapy that reduces hospital treatment time by 160 hours compared to the old standard chemotherapy, allowing patients to live as normal a life as possible."

Data submitted to the regulatory authorities that contributed to the broad approval included pivotal studies on XELOX (Xeloda with oxaliplatin) with or without Avastin and supporting studies on XELIRI (Xeloda in combination with irinotecan) with or without Avastin.

4th February 2008

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