Ziihera (zanidatamab-hrii) + chemotherapy with or without tislelizumab
First-line HER2-positive gastroesophageal adenocarcinoma · Adults with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma
JAZZ · Jazz Pharmaceuticals
监管认定
完整时间线
5 个里程碑FDA decision expected
PDUFA target action date for the zanidatamab combinations sBLA.
Jazz Pharmaceuticals — sBLA acceptance and August 25 action date↗HERIZON-GEA-01 results published in NEJM
The Phase 3 publication further characterized the survival benefit and safety of zanidatamab with chemotherapy, with or without tislelizumab, in first-line HER2-positive advanced GEA.
Jazz Pharmaceuticals — HERIZON-GEA-01 publication update↗FDA accepted the sBLA with Priority Review
FDA accepted the application under Priority Review and Real-Time Oncology Review and assigned an August 25, 2026 target action date.
Jazz Pharmaceuticals — FDA acceptance of the zanidatamab combinations sBLA↗HERIZON-GEA-01 reported positive topline results
Zanidatamab plus chemotherapy improved progression-free survival versus trastuzumab plus chemotherapy, while the zanidatamab, tislelizumab and chemotherapy regimen improved both overall and progression-free survival.
Jazz Pharmaceuticals — Positive Phase 3 HERIZON-GEA-01 results↗相关新闻
暂无相关新闻。