FDA Approves New First-Line Treatment Options for HER2-Positive Advanced Gastric and GEJ Cancer

The U.S. Food and Drug Administration (FDA) has approved new first-line zanidatamab-based treatment options for certain adults with HER2-positive advanced stomach, gastroesophageal junction (GEJ), or esophageal adenocarcinoma. This approval includes a four-drug combination of zanidatamab-hrii (Ziihera), tislelizumab-jsgr (Tevimbra), fluoropyrimidine-based chemotherapy, and platinum-based chemotherapy for tumors testing HER2-positive as IHC 3+ or IHC 2+/ISH+. Additionally, zanidatamab plus fluoropyrimidine- and platinum-containing chemotherapy (without tislelizumab) was approved for patients with HER2 IHC 3+ tumors. A major clinical trial demonstrated that the zanidatamab combination extended survival and delayed cancer progression compared to trastuzumab plus chemotherapy.