Dako: FDA Approval of Diagnostic Tests Provides Hope for Patients with Stomach Cancer

25-Oct-2010 - Denmark

Dako has received approval from the U.S. food and Drug Administration (FDA) to expand the intended use for HercepTest(TM) and HER2 FISH pharmDx(TM) 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.

Sunil S. Badve, MB, BS, FRCPath, professor at the Indiana University, Department of Pathology & Laboratory Medicine (USA) and diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, states: "Dako's HercepTest(TM) and HER2 FISH pharmDx(TM)Kit will be a great advance to the identification of patients with metastatic stomach cancer who are appropriate for HER2 targeted therapy with Herceptin®. The diagnostic tests can identify the group of patients having HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma, and are appropriate candidates for receiving the right combination of targeted treatment and chemotherapy. With these diagnostic kits we now have tools to aid in the selection of a therapy for approx. 22% of the estimated 21,130 Americans who are diagnosed with stomach cancer each year."

The FDA approval of Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) 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.

https://www.bionity.com/en/news/124945/dako-fda-approval-of-diagnostic-tests-provides-hope-for-patients-with-stomach-cancer.html