Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. 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.
“We look forward to working with the FDA and the diagnostic company on this application.”
"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, M.D., executive vice president, Global Development and chief medical officer. "We look forward to working with the FDA and the diagnostic company on this application."