Roche Reports FDA Approval of HER2 Companion Diagnostics for Gastroesophageal Cancer
Shots:
- The US FDA has granted approval to expand the use of Pathway HER2 (4B5) & Ventana HER2 Dual ISH tests to identify HER2+ metastatic gastroesophageal adenocarcinoma (GEA), incl. gastric, GEJ & esophageal adenocarcinoma
- The companion diagnostics can help identify pts who may be eligible for HER2-targeted treatment with two Ziihera (zanidatamab-hrii) regimens for 1L treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA
- Pathway HER2 (4B5) and Ventana HER2 Dual ISH enable precise HER2 assessment, with the latter detecting gene amplification through dual-colour technology, supporting personalized treatment decisions and showing high concordance with HER2 FISH testing
Ref: PRnewswire | Image: Roche | Press Release
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