Swiss healthcare company Roche (SIX: RO, ROG; OTCQX: RHHBY) announced on Wednesday that it has received FDA approval for expanded use of its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH DNA Probe Cocktail tests.

These companion diagnostics are now approved in the United States to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma (GEA) patients, including those with gastric, gastroesophageal junction, and oesophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii). Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA.

This FDA approval broadens the population of patients eligible for HER2-targeted therapies to include those with HER2-positive GEA. Until now, no tests had been approved to determine HER2 status in esophageal cancer, meaning patients were unable to access targeted therapy, Roche said. The tests are already widely used in breast and gastric cancers.