Dako has received approval from the FDA to expand the intended use for HercepTest™ and HER2 FISH pharmDx™ Kit to include patients with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer). Dako’s diagnostic tests are indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered. The FDA has simultaneously approved the use of Herceptin in combination with chemotherapy for HER2-positive, metastatic stomach cancer or cancer of the gastroesophageal junction. Results from a recent clinical study indicate that patients with HER2-positive metastatic stomach cancer live longer when treated with Herceptin in combination with chemotherapy, compared to chemotherapy alone.

The FDA approval of Dako’s HercepTest and HER2 FISH pharmDx Kit for use in stomach cancer patients in the United States is based on the positive results of an international Phase III study (ToGA). In the screening phase for assessing HER2-status, the study involved more than 3,700 patients at 122 sites in 24 countries. The FDA-approved dataset (N=594) showed that treatment with Herceptin in combination with chemotherapy in patients with metastatic HER2-positive stomach cancer found by the use of Dako’s diagnostic tests significantly prolongs the lives of patients with this aggressive cancer.

Stomach cancer is the second most common cause of cancer-related deaths globally with over 1,000,000 new cases diagnosed each year. An estimated 21,130 Americans were diagnosed with stomach cancer and more than 10,600 Americans died from the disease in 2009, according to the American Cancer Society (ACS). More than 64,000 Americans are currently living with the disease. Early diagnosis is challenging because most patients do not show symptoms in the early stage. Approximately one in five of all stomach tumors are HER2-positive.

HercepTest and HER2 FISH pharmDx Kit carry the CE mark in the European Union.

Source: Dako