Roche's Xeloda performs well in Ph III

16 April 2006

Swiss firm Roche says that a Phase III study of its drug Xeloda (capecitabine) as a treatment for advanced gastric cancer has met its primary endpoint. Full data derived from the assessment has been submitted to the American Society of Clinical Oncology for presentation at its upcoming annual meeting in June

The clinical trial was a randomized, open-label comparative examination of the efficacy of Xeloda as part of first-line chemotherapy for patients with advanced or metastatic gastric cancer. The results showed that the compound, given in addition to cisplatin-based chemotherapy, is at least as effective in terms of delaying disease progression as the current leading therapy, intravenous 5-fluorouracil plus cisplatin treatment regimen.

Ed Holdener, Roche's head of global development, commented that the findings were encouraging, adding that Xeloda improves the management of the condition by reducing the in-hospital treatment required to one day, compared with the five-day treatment cycles that are required every three weeks by the current standard therapy. The company says that it is preparing to file for the gastric cancer indication with regulatory bodies worldwide.

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