Jazz Pharmaceuticals announced on August 25, 2026, that the U.S. Food and Drug Administration (FDA) has approved two Ziihera® (zanidatamab-hrii) treatment regimens for adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA). The approval establishes Ziihera as a new first-line treatment option, creating a new standard of care in this patient population.
Key Details
- Approved Regimens: The FDA approved two combinations: Ziihera plus Tevimbra® and chemotherapy for all HER2+ patients, and Ziihera plus chemotherapy for patients with HER2+ IHC 3+ status.
- Clinical Trial Data: Approval was based on the Phase 3 HERIZON-GEA-01 trial, which showed the Ziihera, Tevimbra, and chemotherapy combination extended median overall survival to 26.4 months versus 19.2 months for the control arm.
- Market Significance: Ziihera is now the first bispecific HER2-targeted antibody approved in combination with a PD-1 inhibitor and chemotherapy for first-line HER2+ advanced GEA, regardless of a patient's PD-L1 status.