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Ziihera (ZANIDATAMAB)
Zanidatamab works by binding to two different parts of the HER2 protein, blocking its growth-promoting signals and slowing tumor growth.
Zanidatamab, also known as Ziihera, is a bispecific HER2-directed antibody developed by Jazz Pharmaceuticals. It is a monoclonal antibody that targets HER2-positive biliary tract cancer. Zanidatamab was FDA-approved in 2024 for the treatment of biliary tract cancer. It is a patented product, and its commercial status is not yet generic. Key safety considerations include potential side effects such as fatigue, nausea, and infusion reactions.
At a glance
| Generic name | ZANIDATAMAB |
|---|---|
| Sponsor | Jazz Pharms |
| Drug class | Bispecific HER2-directed Antibody [EPC] |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2024 |
Mechanism of action
Zanidatamab‑hrii is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab‑hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab‑hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.
Approved indications
- biliary tract cancer (BTC)
- biliary tract cancer (BTC)
Boxed warnings
- WARNING: EMBRYO-FETAL TOXICITY Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . WARNING: EMBRYO‑FETAL TOXICITY See full prescribing information for complete boxed warning. • Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception. ( 5.1 )
Common side effects
- Diarrhea
- Abdominal pain
- Fatigue
- Infusion-related reaction
- Nausea
- Vomiting
- Rash
- Decreased appetite
- Biliary obstruction
- Biliary tract infection
- Sepsis
- Pneumonia
Key clinical trials
- Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (PHASE3)
- Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer (PHASE1,PHASE2)
- Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer (PHASE3)
- A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (PHASE3)
- Perioperative Zanidatamab and Chemotherapy for HER2 Positive Gastroesophageal Cancer (PHASE1,PHASE2)
- Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread (PHASE1,PHASE2)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ziihera CI brief — competitive landscape report
- Ziihera updates RSS · CI watch RSS
- Jazz Pharms portfolio CI