Roche said on Wednesday it received U.S. Food and Drug Administration approval for its HER2 tests as companion diagnostics for metastatic gastroesophageal adenocarcinoma, including gastric, gastroesophageal junction and esophageal cancers.
The expanded indication covers the PATHWAY HER2 (4B5) immunohistochemistry test and the VENTANA HER2 Dual ISH DNA Probe Cocktail, both of which are run on Roche’s VENTANA BenchMark slide staining platform. The approval enables clinicians to identify patients eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii), a HER2-targeted therapy approved for first-line use in adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.
Laura Apitz, Head of Pathology Lab at Roche Diagnostics, said the move expands the patient population eligible for targeted therapy by including gastroesophageal adenocarcinoma indications. Previously, no FDA-approved tests existed for determining HER2 status in esophageal cancer, though the same assays were already cleared for breast and gastric cancers.
Gastroesophageal adenocarcinoma encompasses cancers of the stomach, gastroesophageal junction and esophagus. Gastric cancer ranks as the fifth leading cause of cancer deaths globally, while esophageal cancer is the sixth, according to disease prevalence data cited in the announcement.
Roche’s PATHWAY HER2 (4B5) is an immunohistochemistry primary antibody integrated into the VENTANA BenchMark system, while the VENTANA HER2 Dual ISH DNA Probe Cocktail uses dual-color technology to detect HER2 gene amplification. The company did not disclose financial terms related to the approval.
