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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: zanidatamab-hrii
Trade Name: Ziihera
Date Designated: 10/23/2025
Orphan Designation: treatment of esophageal cancer
Orphan Designation Status: Designated/Approved
Jazz Pharmaceuticals Ireland Limited
Fifth Floor, Waterloo Exchange
Waterloo Road
Dublin D04 E5W7
Ireland

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: zanidatamab-hrii
Trade Name: Ziihera
Marketing Approval Date: 08/25/2026
Approved Labeled Indication: (1) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr, for the first-line treatment of adult patients with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test and (2) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-authorized test
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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