Roche said this morning that the first ever Phase III study investigating the benefits of its top-selling oncology drug Xeloda (capecitabine) plus cisplatin in advanced stomach cancer had thrown up positive data showing it to be “at least as effective” as the current gold-standard therapy (5-fluorouracil plus cisplatin) in time to disease progression. The Swiss giant said it now plans to seek approval for this new indication with global regulatory authorities.
The principal benefit of Xeloda in treating stomach cancer was the dramatically reduced time spent in hospital, trimmed from five days every three weeks to just one. And Roche will clearly be hoping that Xeloda – an oral therapy – proves to be a sterling performer in this use: it was first approved in 2001 for advanced colorectal cancer, was cleared last year in Europe and the USA for the adjuvant treatment of colon cancer, and also has labelling for use in combating breast cancer. All this helped it contribute 796 million Swiss francs ($621 million) to the pot last year, up 47%.
Stomach cancer is the fourth most-common tumour type and the second leading cause of cancer-related deaths worldwide, with almost 140,000 fatalities every year in Europe alone. Full data are due to be presented at the American Society of Clinical Oncology meeting later on this year.
