In cohort 1 of the single-arm, phase 2b HERIZON-BTC-01 trial, zanidatamab -- a bispecific antibody that binds two separate sites on the HER2 protein -- produced a confirmed objective response…
In cohort 1 of the single-arm, phase 2b HERIZON-BTC-01 trial, zanidatamab -- a bispecific antibody that binds two separate sites on the HER2 protein -- produced a confirmed objective response…
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Last reviewed
FDA Approvals
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+ by central assessment) biliary tract cancer -- including cholangiocarcinoma and gallbladder cancer -- who had received prior gemcitabine-containing chemotherapy, enrolled in cohort 1 of the multicenter, single-arm, phase 2b HERIZON-BTC-01 trial.
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Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test.
Biomarker requirement
HER2-positive (IHC 3+) by an FDA-approved companion diagnostic
Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study (The Lancet Oncology). DOI 10.1016/S1470-2045(23)00242-5, PMID 37276871.
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