FDA Approves Jazz Pharmaceuticals' Ziihera for First-Line Treatment of HER2+ Gastroesophageal Adenocarcinoma

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Food and Drug Administration (FDA) has approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA). The approval is based on the results of the Phase 3 HERIZON-GEA-01 trial, which demonstrated significant improvements in progression-free survival and overall survival. Ziihera is now the first and only bispecific HER2-targeted antibody combined with a PD-1 inhibitor and chemotherapy approved for all HER2+ advanced GEA patients, regardless of PD-L1 status, establishing a new standard of care in first-line treatment.

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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.