Jazz Pharma Gains FDA Accelerated Approval For Ziihera To Treat HER2-positive Biliary Tract Cancer

(RTTNews) - Jazz Pharmaceuticals plc (JAZZ) announced the U.S. Food and Drug Administration accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.

Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The Phase 3 HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive biliary tract cancer (BTC).

Jazz cautioned that exposure to Ziihera during pregnancy may cause embryo-fetal harm. Patients should be advised of this risk and the necessity of using effective contraception.

According to the company, Zanidatamab is also being investigated in a number of additional tumor types, including Phase 3 trials in gastroesophageal adenocarcinomas (GEAs) and metastatic breast cancer (mBC). The HERIZON-GEA-01 trial evaluating the potential of zanidatamab plus chemotherapy with or without tislelizumab as first-line treatment for patients with advanced/metastatic HER2-positive GEAs. The EmpowHER-303 trial is evaluating the potential of zanidatamab in combination with physician's choice chemotherapy for the treatment of HER2-positive mBC for patients who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment.

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