Genentech, Inc, a wholly owned member of the Roche Group, has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Herceptin (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer. 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.
"This application reflects our commitment to developing more personalized 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," said Hal Barron, executive vice president, Global Development and chief medical officer. "We look forward to working with the FDA and the diagnostic company on this application."
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with serious or life-threatening medical conditions.