By IANS, [RxPG] Swiss pharmaceutical major Roche's study investigating Xeloda (capecitabine) in the first-line treatment of advanced stomach cancer has successfully met its primary endpoint, the company said Monday.
Data from the first-ever phase III clinical study showed that Xeloda, added to another chemotherapy called cisplatin, was at least as effective as the current standard treatment - that uses intravenous 5-fluorouracil plus cisplatin - in terms of time to disease progression, Roche said in a statement.
This international study was a randomised, open-label one of the effect of first-line chemotherapy with Xeloda plus cisplatin versus intravenous 5-fluorouracil plus cisplatin on time to disease progression in patients with advanced or metastatic gastric cancer.
Gastric cancer is the fourth most commonly diagnosed cancer and the second leading cause of cancer-related deaths worldwide. It affects twice as many men as women and occurs more frequently in people aged over 55 years.
Xeloda is licensed in more than 90 countries including the EU, the US, Japan, Australia, Canada and India and has been shown to be an effective, safe, simple and convenient oral chemotherapy.
The oncology market in India is estimated at $30 million. Other cancer drugs from Roche in India include Herceptin and Avastin.
"Full results from the study have been submitted to the American Society of Clinical Oncology (ASCO) for presentation at their annual meeting taking place from June 2-6 in Atlanta, the US," the statement said.
Based on the results of the study, Roche plans to file for an indication in advanced gastric cancer with worldwide regulatory authorities, the company said.
Indo-Asian News Service
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