On Tuesday, the U.S. Food and Drug Administration (FDA) approved Jazz Pharmaceuticals plc’s (NASDAQ:JAZZ) two Ziihera-containing combination regimens as first-line treatments for adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma.
Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne Medicines Ltd (NASDAQ:ONC) under license agreements from Zymeworks Inc. (NASDAQ:ZYME), which first developed the molecule.
FDA Approval Details and Trial Results
The regulatory decision covers Ziihera (zanidatamab-hrii) paired with fluoropyrimidine- and platinum-containing chemotherapy, both with and without BeOne Medicines’ Tevimbra (tislelizumab-jsgr).
Gastroesophageal adenocarcinoma comprises gastric, gastroesophageal junction, and esophageal cancers, ranking as the fifth most common cancer globally. Approximately 20% of patients test positive for HER2, and the United States sees over 31,000 new stomach cancer diagnoses annually.
