Genentech, a wholly owned subsidiary of Roche Group, has submitted a supplemental biologics licence application to the US FDA for Herceptin plus chemotherapy for patients with advanced HER2-positive stomach cancer.
The application is based on the positive results from a Phase III study, which showed that people who received Herceptin plus chemotherapy lived longer compared to those receiving chemotherapy alone.
The randomised Phase III study known as ToGA enrolled 594 patients with locally advanced or metastatic HER2-positive stomach cancer.
According to the American Cancer Society, in 2009, about 21,130 Americans were diagnosed with stomach cancer and more than 10,600 Americans died from the disease. Currently 64,000 are living with the disease.