Drug is being evaluated in Phase III, and test was previously approved for use in breast cancer patients.
Genentech is collaborating with Danish company Dako on U.S. regulatory submissions of the latter’s HercepTest™ and HER2 FISH pharmDx™ as companion diagnostics for Herceptin® in patients with advanced HER2-positive gastric cancer.
Herceptin is not yet licensed in the U.S. for the treatment of stomach cancer, but in May the company reported positive data from the Phase III trial in this patient population. The results showed that patients with advanced HER2-positive stomach cancer who were treated using Herceptin plus chemotherapy lived longer than those given chemotherapy alone.
The immunohistochemistry assay HercepTest was sanctioned in 1998 as the first FDA-approved diagnostic kit designed for use in identifying breast cancer patients eligible for therapy with Herceptin. Dako’s HER2 FISH pharmDx kit is a direct fluorescence in situ hybridization assay designed to quantitatively determine HER2 gene amplification.