FDA approves Ziihera regimens for first-line HER2-positive gastroesophageal adenocarcinoma
U.S. FDA cleared Ziihera regimens for first-line HER2-positive advanced gastroesophageal adenocarcinoma, with tislelizumab and chemotherapy or with chemotherapy alone.
Label covers all HER2-positive patients for the tislelizumab regimen, regardless of PD-L1 status; chemo-only use limited to IHC 3+ disease.
Approval backed by Phase 3 HERIZON-GEA-01 data showing median overall survival of 26.4 months versus 19.2 months for trastuzumab chemotherapy.
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