HERCEPTIN APPROVED FOR HER2+ GASTRIC CANCER

February 2, 2009 — Trastuzumab (Herceptin, Roche) has been approved for use in the treatment of HER2-positive gastric cancer by the European Commission. This is the first approval in the world for this label extension for trastuzumab, which is already marketed for use in the 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 regions of the world are expected to follow soon, says Roche.

Approval for this new indication is based on the results of the international ToGA trial, headed by Eric van Cutsem, MD, PhD, from University Hospital Gasthuisberg in Leuven, Belgium. The results showed that trastuzumab added to chemotherapy significantly prolonged survival — from a median of 11.8 months with chemotherapy alone to a median of 16 months.

When the results from the ToGA trial were first reported at last year's annual meeting of the American Society of Clinical Oncology (ASCO), data were hailed as "practice-changing." ASCO later listed the study as one of the major advances in cancer in 2009.

"The approval of trastuzumab for HER2-positive stomach cancer represents an important advance for the treatment of these patients," Dr. van Cutsem said in a statement. "Clinicians will need to ensure that patients with metastatic stomach cancer are accurately tested for HER2 expression," he added.

Approximately 15% to 18% of gastric tumors show high levels of HER2, according to Roche.

Gastric cancer is the second most common cause of cancer-related death in the world, and is the fourth most commonly diagnosed cancer, with more than 1,000,000 cases diagnosed each year, the company noted in a press release. Advanced stomach cancer is associated with a poor prognosis; the median survival time after diagnosis is approximately 10 to 11 months with currently available therapies. Early diagnosis of this disease is challenging because most patients do not show symptoms in the early stage.

"Trastuzumab is the first targeted biological therapy to show a survival benefit in advanced stomach cancer, and represents a significant advance in the treatment of this devastating disease," said Pascal Soriot, chief operating officer of Roche's Pharmaceuticals Division. "We believe that trastuzumab will help patients with HER2-positive stomach cancer as much as it has helped so many women with HER2-positive breast cancer."

Worldwide, the drug has been used to treat more than 740,000 patients with HER2-positive breast cancer since 1998, the company notes.