Drug Type Bispecific antibody |
Synonyms Zanidatamab (USAN/INN), Zanidatamab-Hrii, JZP598 + [5] |
Target |
Action antagonists, modulators |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), Immunomodulators |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 Nov 2024), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China) |



| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| HER2 Positive Bile Duct Neoplasms | Canada | 01 Jan 2026 | |
| HER2 positive Biliary Tract Neoplasms | United States | 20 Nov 2024 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| HER2 positive Gastrooesophageal junction cancer | NDA/BLA | United States | 29 Apr 2026 | |
| HER2-positive gastric cancer | NDA/BLA | United States | 29 Apr 2026 | |
| HER2 Positive Gastroesophageal Adenocarcinoma | NDA/BLA | United States | 27 Apr 2026 | |
| HER2 Positive Adenocarcinoma of Esophagus | NDA/BLA | China | 13 Apr 2026 | |
| HER2 positive Gastroesophageal Junction Adenocarcinoma | NDA/BLA | China | 13 Apr 2026 | |
| HER2 Positive Stomach Adenocarcinoma | NDA/BLA | China | 13 Apr 2026 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | United States | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Japan | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Australia | 13 Aug 2024 | |
| Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | Austria | 13 Aug 2024 |
Not Applicable | Biliary Tract Neoplasms ERBB2 amplification | single nucleotide variants (SNV) | concurrent amplification and SNVs | 21 | HER2 directed therapy | juztxkbtpb(yxnkyxtfum) = At baseline, ERBB2 alteration patterns included ERBB2 amplification in 15 patients (71.4%), single nucleotide variants (SNV) in 2 patients (9.5%), and concurrent amplification and SNVs in 3 patients (14.3%). ofnuujucfz (tfqvgeaxmi ) | Positive | 29 May 2026 | |
Phase 2 | 46 | Zanidatamab + mFOLFOX6 | hoehtonnio(femnbhgzdj) = tdfwzpkbnh evzjacdflo (ogtzfvcxyn, 8.2 - 21.8) View more | Positive | 29 May 2026 | ||
Phase 3 | 302 | fnzoiaskyb(abtzycdwmn) = bdlucflopc gonzrokzoy (zldttwszoh, 21.5 - 30.3) View more | Positive | 29 May 2026 | |||
(PD-L1 TAP <1%) | fnzoiaskyb(abtzycdwmn) = dasbbokdui gonzrokzoy (zldttwszoh, 24.7 - NE) View more | ||||||
Not Applicable | HER2 expressing | - | ciztkufazb(buiiasovov) = Compared with trastuzumab, zanidatamab showed higher disproportional reporting of gastrointestinal, renal, and cardiovascular events, with strong enrichment for diarrhea (ROR 4.16, 95% CI 3.01-5.74; p < 0.001) and infusion-related reactions (ROR 9.85, 95% CI 6.23-15.59; p < 0.001). Additional positive signals included sepsis, pneumonitis, acute kidney injury, hypokalemia, cerebrovascular accident, stress cardiomyopathy, and hospitalization (all p≤0.006). In contrast, zanidatamab was associated with lower reporting of nausea (ROR 0.41, 95% CI 0.18-0.93; p = 0.024), death (ROR 0.32, 95% CI 0.12-0.86; p = 0.015), and neutropenia (ROR 0.17, 95% CI 0.02-1.18; p = 0.034), with numerically lower disproportionality for anemia, thrombocytopenia, rash, and febrile neutropenia. Signals for pneumonia, chills, colitis, and cardiac failure were numerically elevated but not statistically significant. yagfjsmbrj (xpsxxhsjtc ) View more | Positive | 29 May 2026 | ||
Phase 2 | 80 | (HER2-positive + PD-L1-positive + 1st line HER2/PD-L1-positive GEA) | fezpuwdfod(itzzqxkfky) = fynaflpdom kzkkvtezci (ozuyezkyrq ) View more | Positive | 29 May 2026 | ||
Phase 3 | 914 | fplbcglaaj(hanwsbkoov) = phcaeduflh gbfvvxiblh (ppfmhopfls ) View more | Positive | 28 May 2026 | |||
Zanidatamab + Chemotherapy | fplbcglaaj(hanwsbkoov) = rscgxtngpr gbfvvxiblh (ppfmhopfls ) View more | ||||||
Phase 2 | Neoplasms HER2-expressing | 152 | dijpwkbgts(ulspznzzpo) = rgmbmwglws qwffqyvvpl (xcynpjuuqk ) View more | Positive | 21 Apr 2026 | ||
Phase 3 | 914 | Trastuzumab + CT | uddjcetbpg(wkwvwopplt) = qwtlfprajo ophncfvzqb (ksmtpzjzfe, 7.0 - 8.9) View more | Positive | 08 Jan 2026 | ||
Zanidatamab + CT | uddjcetbpg(wkwvwopplt) = sruozyqpjk ophncfvzqb (ksmtpzjzfe, 9.8 - 14.5) View more | ||||||
Phase 2 | Advanced biliary tract cancer HER2-positive | 62 | (Responders) | byqjzmfpbb(jssnzwfgat): HR = 0.4 (95.0% CI, 0.19 - 0.83) View more | Positive | 08 Jan 2026 | |
(SD) | |||||||
Phase 3 | HER2 Positive Gastroesophageal Adenocarcinoma First line PD-L1 Positive | PD-L1 Negative | HER2 Positive | 914 | mzgxangwzk(gkqsmgvuzc) = Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated highly statistically significant and clinically meaningful improvements, benefit was observed in the Ziihera plus tislelizumab and chemotherapy arm in both PD-L1 positive and PD-L1 negative subgroups. ewmabfrlix (ttzwgbenin ) View more | Positive | 17 Nov 2025 | ||
Ziihera+chemotherapy |






