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news.Roche's Herceptin (trastuzumab), in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]), has received approval from the US Food and Drug Administration (FDA) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for metastatic disease.
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Herceptin is a humanized antibody, designed to target and block the function of HER2, a protein produced by a specific gene with cancer-causing potential.
The FDA approval is based on positive results from an international Phase III study, known as ToGA, which showed that people who received Herceptin plus chemotherapy lived longer compared to those who received chemotherapy alone.
Roche Global Development head and chief medical officer Hal Barron said that since Herceptin’s approval in HER2-positive, they have continued to study how the HER2 pathway contributes to the growth and spread of other cancers, such as stomach cancer.
Herceptin is marketed in the US by Genentech, in Japan by Chugai and internationally by Roche.