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news.Genentech, a member of the Roche Group, has submitted a supplemental biologics license application (sBLA) to the FDA for Herceptin (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer.
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Genentech said that the application is based on positive results from a Phase III study, known as ToGA, which showed that people who received Herceptin plus chemotherapy lived longer compared to people who received chemotherapy alone.
The international Phase III study enrolled 594 people with locally advanced or metastatic HER2-positive stomach cancer who were randomised to receive Herceptin plus chemotherapy (Xeloda [capecitabine tablets] or intravenous 5-flourouracil and cisplatin) or chemotherapy alone.
In the trial, the overall survival (OS), the primary endpoint, was improved in people who received Herceptin plus chemotherapy compared to those who received chemotherapy alone.
Hal Barron, executive vice president of global development and chief medical officer at Genentech, said: “This application reflects our commitment to developing more personalised medicines for people with cancer. By using diagnostics to help identify the right patients for our medicines, it is our hope that Herceptin used with chemotherapy will become the first targeted option for advanced HER2-positive stomach cancer. We look forward to working with the FDA and the diagnostic company on this application.”