Roche receives FDA approval for companion diagnostic tests to identify patients with HER2-positive metastatic gastroesophageal adenocarcinoma eligible for ZIIHERA

Roche announced FDA approval for expanded use of two HER2 companion diagnostic tests—PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail—to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma. The approval covers gastric, gastroesophageal junction, and esophageal adenocarcinoma, enabling clinicians to identify patients who may qualify for HER2-targeted therapy with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii). Roche said two ZIIHERA-containing regimens are now FDA approved for first-line treatment in adults with unresectable locally advanced or metastatic HER2-positive GEA. The company noted there had been no previously approved test to determine HER2 status in esophageal cancer.