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# Jazz Biliary Tract Cancer BLA Approved
- URL: https://www.fdaweb.com/jazz-biliary-tract-cancer-bla-approved/
- Published: 2024-11-22T12:00:00.000Z
- Updated: 2026-09-14T14:47:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158244

FDA has granted Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.

Approval is based on data from the HERIZON-BTC-01 (NCT04466891) open-label, single-arm trial in 62 patients, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanidatamab-hrii-previously-treated-unresectable-or-metastatic-her2?ref=fdaweb.com). The major efficacy outcome measures were objective response rate (52%) and duration of response (14.9 months), it says.

Regarding safety, FDA says the prescribing information requires a boxed warning for embryo-fetal toxicity. “The most common adverse reactions reported in at least 20% of patients who received zanidatamab-hrii were diarrhea, infusion-related reactions, abdominal pain, and fatigue,” it adds.