Xeloda approved in Europe for stomach cancer
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Switzerland’s Roche Holding AG said on Friday its Xeloda drug had been approved in Europe for the treatment of advanced stomach cancer.
Xeloda was approved for first-line use in combination with platinum-based chemotherapy, Roche said in a statement.
The approval had been expected after Xeloda — which is already approved for other conditions — was recommended for stomach cancer last month by a panel of European experts.
The decision was based on data from two late-stage clinical trials. One trial showed that patients given a combination of Xeloda and cisplatin lived at least as long without cancer progressing as those receiving the current standard therapy of cisplatin plus 5-flurouracil. The second study demonstrated Xeloda was as effective as 5-flurouracil and can replace it.
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