Ziihera moves into first-line HER2+ gastroesophageal cancer with FDA approval

The US FDA approved two regimens containing Ziihera (zanidatamab-hrii) for first-line treatment of unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma, marking the drug's second US approval. The approval, supported by Phase III HERIZON-GEA-01 data, allows use regardless of PD-L1 status in one regimen and triggers a $250 million milestone payment to Zymeworks.

This Wire brief sits within Fusion42's coverage of Biotech, and 10 sources have reported it between 25 Aug 2026 and 8 Sep 2026.