Genentech Submits Herceptin sNDA in Stomach Cancer

Genentech, a wholly owned member of the Roche Group, has submitted a sBLA to the 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 the Phase III study ToGA, which showed that people who received Herceptin plus chemotherapy lived longer compared to 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, 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.”