Jazz Pharmaceuticals plc JAZZ

Nasdaq · Approved · oncology · antibody · EDGAR · Updated Oct 24, 2026

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an oncology drug developer. Its lead program, Ziihera (zanidatamab) sBLA, is marketed for HER2+ cancer.

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Program	Indication	Modality	Stage
Ziihera (zanidatamab)	HER2+ biliary/gastroesophageal	antibody	Approved

Aug 25, 2026
approval FDA approved Ziihera plus tislelizumab and chemo (IHC 3+ and 2+/ISH+) and Ziihera plus chemo (IHC 3+) for first-line HER2+ GEA; median OS 26.4 vs 19.2 months and median PFS 12.4 vs 8.1 months in the pivotal trial.today announced that the U.S. Food and Drug Administration (FDA) approved two Ziihera® (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA) Filing
Nov 17, 2025
met Phase 3 (914 patients) met PFS in both Ziihera arms vs trastuzumab plus chemo; Ziihera plus tislelizumab and chemo also significantly improved OS, while Ziihera plus chemo showed a strong trend toward OS significance at first interim.Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to the control arm, trastuzumab plus chemotherapy. Filing

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