Jazz Pharmaceuticals (JAZZ) announced that zanidatamab-hrii – Ziihera – 50 mg/mL for injection for intravenous use is recommended by the National Comprehensive Cancer Network, or NCCN Clinical Practice Guidelines in Oncology as a category 2A treatment option for Biliary Tract Cancers, or BTC. Ziihera was granted accelerated approval by the FDA on November 20, for the treatment of adults with previously treated, unresectable or metastatic HER2-positive BTC, as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Ziihera is now commercially available to prescribers and customers in the U.S. and is available for purchase from authorized Specialty Distributors. The NCCN Guidelines present expert recommendations for cancer screening, diagnosis and treatment, as well as cancer care options, and is utilized in cancer treatment decision-making to drive positive patient outcomes. The NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education.
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