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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.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 pers...

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