Roche announced on Wednesday that the U.S. Food and Drug Administration has approved expanded use of its Pathway HER2 and Ventana HER2 Dual ISH tests to evaluate certain advanced cancers of the upper digestive tract.
The approval covers the assessment of HER2 protein overexpression and gene amplification in specific forms of gastric, esophageal, and gastroesophageal junction cancers. Previously, no FDA-approved test existed for determining HER2 status in esophageal cancer, according to Roche.
The tests identify patients whose tumors exhibit elevated HER2 levels or additional gene copies, a critical factor in determining eligibility for HER2-targeted therapies. This includes patients who may benefit from Jazz Pharmaceuticals' Ziihera, now approved in two U.S. treatment regimens for adults with unresectable, locally advanced, or metastatic HER2-positive gastroesophageal adenocarcinoma.
Roche stated the expanded approval aims to improve diagnostic precision for gastrointestinal cancers, where HER2 status plays a key role in treatment decisions. The Pathway HER2 and Ventana HER2 Dual ISH tests were already in use for other cancer types, but the FDA clearance now extends their application to upper digestive tract malignancies.
The Swiss pharmaceutical group did not disclose financial terms related to the approval.
