← All approvals · Cancer · 2024
Ziihera (zanidatamab-hrii)
The FDA approved Ziihera (zanidatamab-hrii) on November 20, 2024 to treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.
- Brand name
- Ziihera
- Generic name
- zanidatamab-hrii
- FDA approval date
- November 20, 2024
- Approved use (FDA wording)
- To treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer
- Company
- Jazz Pharms
- Application
- BLA761416
- Dosage form / route
- INJECTABLE · INJECTION
- Drug class (EPC)
- Bispecific HER2-directed Antibody [EPC]
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Cancer
Indications and usage, from the FDA label
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. ( 1.1 ) • 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,…