U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma
The FDA approved Jazz Pharmaceuticals' Ziihera for two first-line regimens in HER2-positive advanced gastroesophageal adenocarcinoma (GEA), establishing it as the first bispecific HER2-targeted antibody approved in this setting regardless of PD-L1 status. Approval was based on the Phase 3 HERIZON-GEA-01 trial, where the Ziihera combination demonstrated a median overall survival of 26.4 months and median progression-free survival of 12.4 months.
Key figures
- Drug Name
- Ziihera (zanidatamab-hrii)
- Phase Of Trial
- Phase 3
- Median os months
- 26.4
- Median pfs months
- 12.4
- Os risk reduction percent
- 28
- Pfs risk reduction percent
- 35
AI analysis
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