Zanidatamab FDA Approval Status
Last updated by Judith Stewart, BPharm on June 3, 2024.
FDA Approved: No
Generic name: zanidatamab
Company: Jazz Pharmaceuticals plc
Treatment for: Biliary Tract Tumor
Zanidatamab is a biparatopic HER2-targeted bispecific antibody in development for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC).
- The human epidermal growth factor receptor 2 (HER2) is an established target for antitumor therapy in other cancers, including breast cancer and gastroesophageal adenocarcinoma. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in the U.S.
- Zanidatamab can simultaneously bind to two non-overlapping epitopes of HER2 resulting in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity.
- The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified biliary tract cancers (BTC), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA.
Development timeline for zanidatamab
Further information
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