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Getting the latest healthcare news for you
The FDA has approved Ziihera (zanidatamab-hrii), a bispecific HER2 antibody, with or without the PD-1 inhibitor tislelizumab, plus chemotherapy for first-line treatment of HER2-positive advanced gastroesophageal adenocarcinoma (GEA). In the pivotal HERIZON-GEA-01 trial, the triplet regimen delivered a median overall survival of 26.4 months vs. 19.2 months with the current standard of trastuzumab plus chemo — a meaningful leap forward for a tough-to-treat cancer.
The FDA has approved Ziihera (zanidatamab-hrii, Jazz Pharmaceuticals) in two new regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA). The bispecific HER2-directed antibody can now be used with fluoropyrimidine- and platinum-based chemotherapy alone, or in combination with the PD-1 inhibitor tislelizumab-jsgr (Tevimbra). Two companion diagnostic tests from Roche were also approved to identify eligible patients.
The approval was based on the 914-patient HERIZON-GEA-01 trial, which compared zanidatamab-based regimens head-to-head against the current standard of trastuzumab plus chemotherapy. The triplet combination (zanidatamab + tislelizumab + chemo) showed significant improvements in both progression-free and overall survival — and crucially, the benefit held regardless of PD-L1 expression status, suggesting broad applicability. Experts are calling zanidatamab the new standard of care, replacing trastuzumab in the first-line setting.
By the Numbers
Why it matters: GEA carries a poor prognosis, and the current trastuzumab-based standard has long needed an upgrade. Zanidatamab's superior efficacy across PD-L1 positive and negative patients — and both HER2 IHC 2+ and 3+ tumors — makes it a broadly applicable new option for a patient population with limited choices.
