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Jazz Pharma Seeking Approval for Zanidatamab in HER2-Positive Biliary Tract Cancer

NEW YORK – Jazz Pharmaceuticals said on Wednesday that the US Food and Drug Administration has accepted its biologics license application (BLA) for zanidatamab as a second-line treatment for unresectable, locally advanced or metastatic HER2-positive biliary tract cancer.

The FDA granted priority review to the zanidatamab BLA and assigned a target Prescription Drug User Fee Act (PDUFA) date of Nov. 29, 2024.

The submission was based on results from the Phase IIb HERIZON-BTC-01 clinical trial. Data presented last year showed a 41.3 percent confirmed objective response rate on zanidatamab in 80 patients with HER2-positive biliary tract cancer. Jazz said updated data from the trial will be presented at the American Society of Clinical Oncology annual meeting in June, including overall survival, duration of response, and other long-term follow-up results.

Jazz licensed zanidatamab from Zymeworks in the US, Europe, Japan, and other territories in 2022. The firm is also conducting a Phase III trial evaluating zanidatamab with chemotherapy and immunotherapy against chemo and immunotherapy alone as a first-line treatment for HER2-positive biliary tract cancer. This trial is expected to be the confirmatory trial for zanidatamab in this setting.

Jazz is also exploring zanidatamab in other HER2-expressing tumors, including in breast cancer and in a tissue-agnostic setting.