Jazz Pharmaceuticals plc
Jazz Pharmaceuticals Announces Positive Phase 3 Results for Ziihera in HER2+ Gastroesophageal Adenocarcinoma
Summary
Jazz Pharmaceuticals plc announced on November 17, 2025, positive top-line results from the Phase 3 HERIZON-GEA-01 trial for Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without tislelizumab, as a first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The trial demonstrated clinically meaningful and statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to the control arm, trastuzumab plus chemotherapy. Ziihera plus tislelizumab and chemotherapy also showed improvements in objective response rate (ORR) and duration of response (DoR). The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA in the first half of 2026.
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About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc is a global biopharmaceutical company that focuses on developing life-changing medicines for patients in various therapeutic areas. The company's primary function is to research, manufacture, and market drugs that address unmet medical needs, particularly in the fields of neuroscience, oncology, and sleep medicine. Jazz Pharmaceuticals has gained prominence for its innovative products such as Xyrem, used for treating narcolepsy, and Vyxeos, a treatment for certain types of leukemia. Headquartered in Dublin, Ireland, the company operates extensively across North America and Europe, working to advance scientific research in pharmaceuticals. By prioritizing patient care and survival, Jazz Pharmaceuticals plays a significant role in the pharmaceutical industry with its commitment to developing novel therapies. Moreover, the company's strategic collaborations and acquisitions enable it to expand its product portfolio and impact the healthcare sector positively. Jazz Pharmaceuticals continues to be a key player in transforming patient care for complex conditions.
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