'Practice-Changing' Data Expand Zanidatamab's Approval to Gastroesophageal Cancer
(MedPage Today) -- The FDA approved zanidatamab (Ziihera) plus tislelizumab (Tevimbra) and chemotherapy as first-line treatment for unresectable/metastatic HER2-positive gastroesophageal cancer. The approval stipulates use in adults with unresectable...
The FDA recently expanded the approval of zanidatamab (Ziihera) to include gastroesophageal cancer (GEA) as a first-line treatment option. This decision applies to patients with unresectable/metastatic HER2-positive gastroesophageal cancer, regardless of whether their tumors are PD-L1 positive or negative. The expanded approval allows zanidatamab to be used in combination with platinum-containing chemotherapy, either alongside or without the PD-1 inhibitor tislelizumab (Tevimbra).
The approval, supported by data from the randomized phase III HERIZON-GEA-01 trial, demonstrates a significant improvement in overall survival (OS) and progression-free survival (PFS) for patients receiving zanidatamab plus chemotherapy compared to trastuzumab plus chemotherapy. The most frequently reported side effect was diarrhea, experienced by 75% of those treated with zanidatamab versus 48% in the control group.
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