Patients newly diagnosed with an aggressive cancer of the stomach, esophagus or the junction between them now have two additional treatment options at the very start of care. Federal regulators approved two combinations featuring Ziihera, the brand name for zanidatamab, for adults with unresectable, locally advanced, or metastatic HER2-positive gastroesophageal adenocarcinoma.
The FDA also approved two companion diagnostic devices to identify eligible patients: the PATHWAY anti-HER2/neu antibody test and the VENTANA HER2 Dual ISH DNA Probe Cocktail, according to oncology coverage of the decision. That pairing matters more than it sounds, because eligibility here depends entirely on a tumor test result rather than on symptoms or stage alone.
