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Roche wins FDA approval for expanded use of HER2 companion tests in metastatic gastroesophageal adenocarcinoma

26. Aug 2026

(AWP Alliance News) - Roche received FDA clearance to expand use of its PATHWAY HER2 (4B5) and VENTANA HER2 Dual ISH tests as companion diagnostics for HER2-positive metastatic gastroesophageal adenocarcinoma. The move enables identification of patients eligible for Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii) in first-line unresectable locally advanced or metastatic disease.

https://www.prnewswire.com/news-releases/roche-receives-fda-approval-fo…

Disclaimer: This news brief was created using generative artificial intelligence. Roche Holding AG published the original content used to generate this news brief via PR Newswire on August 26, 2026, and is solely responsible for the information contained therein.

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