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Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has approved two zanidatamab-hrii (Ziihera) regimens as first-line treatments for adults with unresectable or metastatic HER2-positive gastroesophageal adenocarcinoma. Backed by the HERIZON-GEA-01 trial, the drug showed significant improvements in progression-free and overall survival over trastuzumab. Experts say zanidatamab is poised to become the new standard of care in this setting.
The FDA has approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in two first-line regimens for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma. The drug can now be used with fluoropyrimidine- and platinum-based chemotherapy alone, or in a triplet combination that also includes the PD-1 inhibitor tislelizumab-jsgr (Tevimbra).
The approvals are grounded in the randomized, three-arm HERIZON-GEA-01 trial, which enrolled 914 patients and compared zanidatamab-based regimens against the previous standard, trastuzumab plus chemotherapy. The results were compelling enough that lead investigators are calling zanidatamab a superior anti-HER2 agent and the new standard of care. Two companion diagnostics were also approved to help identify eligible patients.
By the Numbers:
Why it matters: HER2-positive gastroesophageal cancer carries a poor prognosis, and trastuzumab has been the cornerstone of first-line treatment for over a decade. This approval marks a meaningful shift, offering patients a more effective option — though proactive diarrhea management will be critical to keeping patients on therapy.
