Xeloda filed in EU for stomach cancer

Switzerland-based drug major Roche says that the European Medicines Agency (EMEA) has accepted the firm's anticancer agent Xeloda (capecitabine) for regulatory review to further extend its indication. Currently, the drug is approved in the European Union and USA both as a monotherapy and post surgical therapeutic ajuvant for use in the treatment of metastatic colorectal cancer, as well as in combination with docetaxel in metastatic breast cancer therapy.

The submission, which requests approval for the drug in addition to chemotherapy (cisplatin) in the treatment of stomach cancer, is based on a Phase III trial that compared the combined regimen with the standard infusional 5-flurouracil plus cisplatin therapy. The results showed that combined Xeloda plus cisplatin was non-inferior to the standard therapy in terms of time-to-disease-progression. In addition, the trial data showed that the response rate to Xeloda and cisplatin was superior to 5-FU and cisplatin.

The company said that Xeloda is effective in treating the disease, as well as providing a simplified oral regimen that reduces the need for hospital visits. The firm added that the the drug would allow the EU's estimated 140,000 stomach cancer patients a greater degree of freedom during therapy.