Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. 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 that has spread) cancer of the stomach or gastroesophageal junction, in men and women who have not received prior medicines for their metastatic disease.
“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.”
People diagnosed with metastatic stomach cancer should have the HER2 status of their tumors determined with FDA-approved diagnostic tests, as only people 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, M.D., executive vice president, Product Development and chief medical officer. "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."
In January 2010, the European Commission approved Herceptin in combination with chemotherapy for people with metastatic stomach (gastric) cancer with tumors exhibiting high levels of HER2.