On 27 April 2026, Jazz Pharmaceuticals announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) in combination with BeOne’s (formerly BeiGene’s) Tevimbra® (tislelizumab) and chemotherapy for the first-line treatment of adult patients with HER2+ advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA).
The sBLA is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA’s evaluation of the application. The FDA has set a target action date under the Prescription Drug Fee Act (PDUFA) of 25 August 2026.
The sBLA was based on positive safety and efficacy results from the global, randomised Phase III HERIZON-GEA-01 trial, which evaluated the efficacy and safety of Ziihera® in combination with standard-of-care chemotherapy with or without Tevimbra® in patients with advanced or metastatic GEA, including gastric, GEJ and oesophageal adenocarcinomas.
Jazz Pharmaceuticals also announced on 27 April 2026 that the FDA has granted Breakthrough Therapy designation to zanidatamab in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, for the first-line treatment of patients with HER2+ unresectable locally advanced or metastatic gastric, GEJ, or oesophageal adenocarcinoma.
Zanidatamab is being developed by Jazz and BeOne under licence agreements from Zymeworks, which first developed the molecule. Jazz has rights to zanidatamab in all regions except Asia (excluding India and Japan), Australia and New Zealand, for which BeOne has the rights.