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On August 25, 2026, the U.S. Food and Drug Administration approved two Ziihera (zanidatamab-hrii)-containing regimens…
JAZZJazz Pharmaceuticals plc
On August 25, 2026, the U.S. Food and Drug Administration approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. The approvals cover Ziihera combined with Tevimbra (tislelizumab-jsgr) and chemotherapy for all HER2+ patients, as well as Ziihera plus chemotherapy for HER2+ IHC 3+ patients. This approval is based on the Phase 3 HERIZON-GEA-01 trial, which reported a median overall survival of 26.4 months versus 19.2 months for the control arm. Jazz Pharmaceuticals plc operates in the biopharmaceutical industry, developing and commercializing medicines for rare diseases, including cancers and sleep disorders.