First-Line HER2-Positive Gastroesophageal Adenocarcinoma
ONCBeOne MedicinesCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for TEVIMBRA/Tislelizumab + ZIIHERA/Zanidatamab (PD-1 Antibody) in First-Line HER2-Positive Gastroesophageal Adenocarcinoma. The expected timing is based on the latest available company guidance and may change.
02/26/26:- HERIZON-GEA-01 overall survival benefit supports planned supplemental BLA submissions for first-line HER2-positive GEA in H1 2026. 04/29/26:- FDA granted Priority Review for sBLA; IA1 OS 26.4 months, PFS 12.4 months. 05/06/26:- United States regulatory decision for first-line HER2-positive GEA combination expected in H2 2026; China decision anticipated in H1 2027. 08/05/26:- HERIZON-GEA-01 NEJM results published; U.S. action remains H2 2026.
Verification
Confirm timing and program details against the company announcement or filing.