NEW YORK – The US Food and Drug Administration on Wednesday granted accelerated approval to Jazz Pharmaceuticals' Ziihera (zanidatamab) as a treatment for advanced HER2-positive biliary tract cancer.
The agency approved the HER2-targeted bispecific antibody for previously treated patients with metastatic or unresectable tumors that have HER2 immunohistochemistry scores of 3+, according to an FDA-approved test.
The approval is based on the results of the Phase IIb HERIZON-BTC-01 clinical trial, in which Ziihera led to a 52 percent objective response rate in a cohort of 62 patients. The median duration of response was 14.9 months. In the clinical trial, Jazz used Roche's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody companion diagnostic to assess patients' HER2 expression levels.
Because the drug is approved under accelerated approval, Jazz will continue to evaluate its efficacy in a Phase III confirmatory trial dubbed HERIZON-BTC-302. In that trial, the firm is evaluating frontline Ziihera combined with standard of care versus standard of care alone.
Dublin-based Jazz, which licensed Ziihera from Zymeworks in the US, Europe, Japan, and other territories in 2022, is also evaluating the agent in HER2-expressing breast cancer and in a tissue-agnostic setting.