FDA Approves Expanded Ziihera Use for First-Line HER2-Positive Advanced GEA
Jazz Pharmaceuticals said the FDA approved a label expansion for Ziihera, authorizing first-line treatment for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma in combination with a PD-1 inhibitor and chemotherapy, regardless of PD-L1 status. The approval makes Ziihera the first bispecific HER2-targeted antibody in this first-line regimen and expands its addressable market.