US pharmaceutical company Jazz Pharmaceuticals plc (Nasdaq:JAZZ) announced on Monday that the US Food and Drug Administration (FDA) has accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera (zanditatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA).

The FDA has set a PDUFA target action date of 25 August 2026.

The sBLA is supported by data from the pivotal HERIZON-GEA-01 trial to investigate the efficacy and safety of zanidatamab in combination with standard-of-care chemotherapy with or without the PD-1 inhibitor Tevimbra (tislelizumab) in patients with advanced or metastatic GEA, including gastric, GEJ and oesophageal adenocarcinomas. The submission is under review via the Real-Time Oncology Review (RTOR) program, an initiative of FDA's Oncology Center of Excellence designed to provide a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

The FDA 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 esophageal adenocarcinoma. Breakthrough Therapy designation is intended to expedite the development and review of therapies that, based on preliminary clinical evidence, may offer substantial improvement over available therapies on one or more clinically significant endpoints, reflecting both the seriousness of the disease and the unmet medical need in this setting.