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Home Industry News Roche stomach cancer drug gets EC approval

Roche stomach cancer drug gets EC approval

30th March 2007

Roche has announced that its stomach cancer drug Xeloda (capecitabine) has gained approval from the European Commission (EC) for use as a first line treatment for advanced stomach cancer in conjunction with platinum-based chemotherapy.

The company notes that Xeloda, an orally-administered chemotherapy product, has replaced traditional intravenous therapy 5-fluorouracil (5-FU) as a treatment in other forms of gastrointestinal cancer before attaining this approval.

Approval of the compound follows the completion of the Real 2 and ML17032 clinical trials showing that patients administered with Xeloda lived as long, or longer, than those treated with 5-FU.

Professor YK Kang of the Asan Medical Centre notes that previous stomach cancer treatment relied on intravenous pumps which some patients can find uncomfortable and inconvenient to use, while Xeloda reduces the time spent by patients in hospital by 80 per cent.

William M Burns, chief executive officer of Roche Pharma, said: “The news from the EC is welcome by both patients and physicians.”

He added that Xelod can provide patients with an orally-administered therapy for “aggressive and debilitating” stomach cancer which requires less hospital visits resulting in increased flexibility for patients and greater cost-effectiveness than other treatments.

This approval follows the granting of a positive opinion on the compound from the European Committee for Medicinal Products for Human Use issued last month.

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