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Jazz Pharmaceuticals Announces Update to National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Biliary Tract Cancers to Include zanidatamab-hrii (Ziihera®)
Ziihera, the first and only FDA-approved dual HER2-targeted bispecific antibody for HER2+ (IHC 3+) BTC, is now commercially available in the United States For
About this update from Jazz Pharmaceuticals Plc
[{"type":"text","content":"Ziihera, the first and only FDA-approved dual HER2-targeted bispecific antibody for HER2+ (IHC 3+) BTC, is now commercially available in the United States\nFor U.S. media and investors only\nDUBLIN, Dec. 5, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that zanidatamab-hrii (Ziihera®) 50 mg/mL for injection for intravenous use is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A treatment option for Biliary Tract Cancers (BTC).\nZiihera was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on November 20, 2024, for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an FDA-approved test. The FDA approval of Ziihera was based on results from the HERIZON-BTC-01 clinical trial including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 Ziihera is now commercially available to prescribers and customers in the U.S. and is available for purchase from authorized Specialty Distributors.\n\"The addition of Ziihera to the NCCN Guidelines® in Oncology reaffirms the importance of this advancement in treating BTC and supports our commitment to ensuring that HER2-positive BTC patients, through their health care professionals, can access this important new therapeutic option,\" said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. \"Ziihera is the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for patients living with BTC – a disease with a poor prognosis and limited treatment options. We are excited to deliver this new treatment option to patients in the United States following its accelerated approval.\"\nThe NCCN Guidelines play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, di...