Roche received U.S. Food and Drug Administration approval to expand the use of its PATHWAY HER2 (4B5) test and VENTANA HER2 Dual ISH DNA Probe Cocktail as companion diagnostics for HER2-positive metastatic gastroesophageal adenocarcinoma. The approval covers gastric, gastroesophageal junction and esophageal adenocarcinoma and helps clinicians identify adults who may be eligible for Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii). Two ZIIHERA-containing regimens are FDA approved for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. The decision also marks the first approval of tests to determine HER2 status in esophageal cancer, according to Roche, potentially expanding targeted-treatment options for an aggressive group of cancers often diagnosed at an advanced stage.