Jazz — Ziihera EMA EPAR public assessment report (EMEA/H/C/006380, 2025)
Jazz · 2025 · EMA EPAR public assessment report · company profile →
Report summary
The EMA received a marketing authorization application for Ziihera (zanidatamab) for previously treated, unresectable locally advanced or metastatic HER2-positive biliary tract cancer (BTC). Ziihera, an orphan medicinal product, was not granted accelerated assessment. The application is based on data from Phase 1 (ZWI-ZW25-101) and Phase 2B (ZWI-ZW25-203) studies. Zanidatamab is a HER2-targeting bispecific antibody. Study 203, a pivotal single-arm trial, demonstrated a clinically meaningful ORR of 41.3% and a sustained DOR of 14.92 months. The product quality is acceptable. Non-clinical studies demonstrate Zanidatamab's binding affinity to HER2, its mechanism of action including HER2 downregulation and immune effector activation, and its dose-dependent tumor growth inhibition. The conditional marketing authorization for zanidatamab (Ziihera) as monotherapy for HER2-positive (IHC3+) biliary tract cancer (BTC) in the 2L+ setting, where no standard of care exists, is based on durable confirmed objective response rates from a single-arm trial, with a confirmatory Phase III study (JZP598-302) ongoing to provide comprehensive efficacy and long-term safety data.
Key findings — cited to the page
| Grade 5 AEs (Deaths) | 3.4 % | Study 203 · p.152 |
| Diarrhoea (Grade 3 or Higher) | 8.0 % | Study 203 · p.155 |
| Grade 3 or higher AEs | 63.2 % | Study 203 · p.152 |
| Grade 4 AEs | 5.2 % | 20 mg/kg Q2W Population · p.152 |
| Grade 3 or Higher Treatment-Emergent Adverse Events (Any AE) | 63.2 % | Study 203 · p.154 |
| Grade 3 or Higher Treatment-Emergent Adverse Events (Any AE) | 49.8 % | 20 mg/kg Q2W Population · p.154 |
| Grade 3 AEs | 54.0 % | Study 203 · p.152 |
| Grade 3 AEs | 42.1 % | 20 mg/kg Q2W Population · p.152 |
| Grade 3 or higher AEs | 49.8 % | 20 mg/kg Q2W Population · p.152 |
| Grade 4 AEs | 5.7 % | Study 203 · p.152 |
| Grade 5 AEs (Deaths) | 2.6 % | 20 mg/kg Q2W Population · p.152 |
| Diarrhoea (Grade 3 or Higher) | 5.2 % | 20 mg/kg Q2W Population · p.155 |
Source: Jazz ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →