Jazz Pharmaceuticals received FDA approval on August 25, 2026, for the expanded use of Ziihera (zanidatamab-hrii). The approval covers first-line treatment for adults with HER2-positive advanced or metastatic gastroesophageal adenocarcinoma. This decision broadens the drug's market from its previous indication for late-line biliary tract cancer.
The FDA approved the bispecific antibody for use in combination with chemotherapy. It also cleared a triplet therapy involving chemotherapy and BeOne Medicines' PD-1 inhibitor, Tevimbra. These combinations establish a new standard of care for this type of stomach cancer.
Phase 3 trial results showed the Ziihera-based regimen reduced the risk of death by 28%. The treatment extended median overall survival to 26.4 months. Analysts project this new indication could generate peak annual sales exceeding $1.5 billion.