Jazz Pharmaceuticals launches Ziihera following FDA approval for GEA

Jazz Pharmaceuticals has announced the U.S. commercial launch of Ziihera (zanidatamab) following FDA approval for the treatment of first-line HER2-positive unresectable, locally advanced, or metastatic gastroesophageal adenocarcinoma (GEA).

The therapy is approved for use in combination with tislelizumab and platinum-containing chemotherapy for patients with HER2 IHC 3+ or IHC 2+ and ISH-positive tumors. It is also approved for use with chemotherapy alone for patients with HER2 IHC 3+ disease.

Clinical data from the Phase III HERIZON-GEA-01 trial supported the approval. The study showed that the triplet regimen of Ziihera, tislelizumab, and chemotherapy resulted in a median overall survival of 26.4 months, a 28% reduction in the risk of death compared to a trastuzumab control arm. Additionally, the treatment demonstrated a 35% reduction in the risk of progression or death versus the control arm.