The U.S. Food and Drug Administration has approved Roche’s PATHWAY HER2 (4B5) immunohistochemistry test and VENTANA HER2 Dual ISH DNA Probe Cocktail as companion diagnostics for patients with metastatic gastroesophageal adenocarcinoma, including gastric, gastroesophageal junction, and esophageal cancers.
The approval enables physicians to assess HER2-positive status in tumors where no prior FDA-approved test existed for esophageal cancer. Both assays were previously cleared for breast and gastric cancer indications.
The move facilitates patient eligibility for treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii), a HER2-targeted therapy. The FDA has also approved two zanidatamab-based regimens for first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastroesophageal adenocarcinoma.
Gastric cancer ranks as the fifth leading cause of cancer deaths globally, while esophageal cancer is the sixth, underscoring the clinical significance of expanded diagnostic options. Laura Apitz, head of the Pathology Laboratory at Roche Diagnostics, noted that adding gastroesophageal adenocarcinoma to the approved indications for the widely available HER2 test broadens the population eligible for targeted therapy.
