Jazz Pharmaceuticals (NASDAQ:JAZZ) announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its supplemental Biologics License Application (sBLA) for Ziihera (zanidatamab-hrii).
The application seeks approval for Ziihera in combination with chemotherapy, with or without tislelizumab, as a first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026.
The submission is being processed under the Real-Time Oncology Review (RTOR) program, an initiative designed to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
The sBLA is supported by pivotal data from the HERIZON-GEA-01 clinical trial.
These results demonstrated significant clinical benefit when zanidatamab—a HER2-targeted bispecific antibody—was added to standard chemotherapy regimens.
Due to the potential for zanidatamab to provide a substantial improvement over available therapies, the FDA had previously granted the combination Breakthrough Therapy designation.
Gastric and gastroesophageal cancers remain significant global health challenges, often diagnosed at advanced stages where HER2 overexpression plays a critical role in disease progression.
If approved, Ziihera would offer a novel dual HER2-targeting mechanism, potentially setting a new benchmark for first-line care in this patient population.