Roche announced on Wednesday that the U.S. Food and Drug Administration (FDA) has approved expanded use of its Pathway HER2 and Ventana HER2 Dual ISH cancer tests to assess HER2 status in certain advanced cancers of the upper digestive tract.
The approval covers testing for HER2 protein overexpression and gene amplification in gastric, esophageal, and gastroesophageal junction cancers. Previously, no FDA-cleared test existed for determining HER2 status in esophageal cancer, the company stated. The tests are already in use for other cancer types.
Results from the assays help clinicians identify patients eligible for HER2-targeted therapies, including Jazz Pharmaceuticals’ Ziihera. In the U.S., two treatment regimens featuring Ziihera are now authorized for first-line treatment of adults with unresectable, locally advanced, or metastatic HER2-positive gastroesophageal adenocarcinoma.
Roche, headquartered in Basel, Switzerland, did not disclose financial terms related to the FDA clearance or potential revenue impact from the expanded test applications.
