Dako has received the US Food and Drug Administration (FDA) approval to expand the intended use for HercepTest and HER2 FISH pharmDx Kit to test patients with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer).
The FDA has approved the use of Herceptin in combination with chemotherapy for HER2-positive, metastatic stomach cancer or gastroesophageal junction cancer.
The FDA approval of Dako’s HercepTest and HER2 FISH pharmDx Kit in the US is based on the positive results of an international Phase III study (ToGA), which showed that lives of cancer patients can be prolonged.
Dako Lars CEO Holmkvist said that they have seen Dako’s HercepTest and HER2 FISH pharmDx Kit combined with Herceptin treatment have revolutionised the field of breast cancer.
“It is our hope that these diagnostic kits will help patients with HER2-positive stomach cancer just as much,” Holmkvist said.