U.S. License Holder:
Jazz Pharms
Date of License:
November-20-2024
Last Update:
September-08-2026
FDA-Approved Indications
ZIIHERA (zanidatamab-hrii) is a bispecific HER2-directed antibody indicated for:
ZIIHERA is a bispecific HER2-directed antibody indicated for:
Gastroesophageal Adenocarcinoma (GEA): in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as 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; in combination with fluoropyrimidine- and platinum-containing chemotherapy, as 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;
Biliary Tract Cancer (BTC): for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3 plus) biliary tract cancer (BTC), as detected by an FDA-authorized test.
