U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma

The U.S. FDA has approved Ziihera® (zanidatamab-hrii) in combination with tislelizumab and chemotherapy for the first-line treatment of HER2+ advanced gastroesophageal adenocarcinoma, including patients with IHC 3+ and IHC 2+/ISH+. This approval applies regardless of PD-L1 status. The decision provides a new treatment option for these patients.

Sources

• Business Insider — U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma

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