Molecular Pathology Laboratory Network

Trastuzumab (Herceptin, Roche) was recently approved for use in treatment of HER2-positive gastric cancer by the European Commission. This approval is the first in the world for label extension of trastuzumab, which is already marketed for use in treatment of HER2-positive breast cancer.

This marketing authorization is effective immediately in all European Union countries, and in Iceland, Liechtenstein, and Norway, according to the manufacturer. Similar approvals for this label extension in other international regions are expected to follow soon, Roche said. Approval for this new indication is based on results from the international ToGA trial, which showed that trastuzumab added to chemotherapy significantly prolonged survival.

Approximately 15% to 18% of gastric tumors show high levels of HER2, according to Roche. Gastric cancer is the fourth most commonly diagnosed cancer, with more than 1,000,000 cases diagnosed each year. Advanced stomach cancer is associated with a poor prognosis; and early diagnosis of this disease is challenging because most patients do not show symptoms in the early stage.

MPLN assists physicians with detecting HER2 using immunohistochemistry technology. For more information about this test, contact a technical service specialist at 800.932.2943.