Ziihera FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 21, 2024.
FDA Approved: Yes (First approved November 20, 2024)
Brand name: Ziihera
Generic name: zanidatamab-hrii
Dosage form: Lyophilized Powder for Injection
Company: Jazz Pharmaceuticals plc
Treatment for: Biliary Tract Tumor
Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody for the treatment of HER2-positive biliary tract cancer.
- Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - Biliary tract cancer consists of tumors that arise from epithelial cells lining the biliary tract. Human epidermal growth factor receptor-2 (HER2) plays a critical role in certain cancers, and HER2 is an established target for antitumor therapy in breast cancer and gastroesophageal adenocarcinoma. A growing body of literature has demonstrated that HER2 is also involved in biliary tract cancers.
- Ziihera works in the treatment of HER2-positive BTC by binding to two extracellular sites on HER2 which leads to a reduction of the receptor on the tumor cell surface. Ziihera induces complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis which results in tumor growth inhibition and tumor cell death.
- FDA accelerated approval of Ziihera was based on results from the HERIZON-BTC-01 clinical trial which demonstrated an objective response rate (ORR) of 52% with a Kaplan Meier estimated median duration of response (DOR) of 14.9 months.
- Ziihera is administered as an intravenous infusion once every 2 weeks. Premedication with acetaminophen, an antihistamine and a corticosteroid is recomended 30-60 minutes prior to each infusion to prevent potential infusion-related reactions.
- Ziihera carries a Boxed Warning for embryofetal toxicity. Warnings and precautions include left ventricular dysfunction, infusion-related reactions, and severe diarrhea.
- Common adverse reactions (≥ 20%) include diarrhea, infusion-related reaction, abdominal pain, and fatigue.
Development timeline for Ziihera
Further information
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