Roche announced the US Food and Drug Administration (FDA) has approved Herceptin (trastuzumab) in combination with chemotherapy (cisplatin plus either capecitabine or 5-fluorouracil [5-FU]) for HER2-positive metastatic cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.

People diagnosed with metastatic stomach cancer should have the HER2 status of their tumours determined, as only patients with HER2-positive disease are eligible for treatment with Herceptin plus chemotherapy.  

“Since Herceptin’s approval in HER2-positive, advanced breast cancer more than a decade ago, we have continued to study how the HER2 pathway contributes to the growth and spread of other cancers, such as stomach cancer,” said Hal Barron, head of Global Development and chief medical officer at Roche. “Today’s approval of Herceptin in combination with chemotherapy provides an important new, personalized medicine for people with this life-threatening disease, who have few treatment options.”

The European Commission approved Herceptin in combination with chemotherapy for use in patients with metastatic stomach (gastric) cancer exhibiting high levels of HER2, in January 2010.

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.