, /PRNewswire/ -- "The priority review designation for zanidatamab underscores the critical need for new treatment options for patients with locally advanced or metastatic HER2-positive BTC, a devastating disease with a poor prognosis," said , M.D., M.
S.C.E.
, executive vice president, global head of research and development of Jazz Pharmaceuticals. "Upon approval, zanidatamab will be the first HER2-targeted treatment specifically indicated for these patients, and we look forward to the opportunity to deliver this new treatment option to the BTC community." Jazz's BLA submission is based on results from Cohort 1 of the Phase HERIZON-BTC-01 clinical trial ( ) of zanidatamab in previously treated patients with unresectable, locally advanced, or metastatic HER2-positive BTC (defined as in situ hybridization [ISH] positive and immunohistochemistry [IHC] 2+ or 3+).
The trial demonstrated a primary endpoint of 41.3% [95% confidence interval (CI): 30.4, 52.
8] confirmed objective response rate (cORR) by independent central review (ICR) and results were presented at the , published in and included in the 2023 Best of ASCO program Overall survival, updated duration of response and additional long-term follow-up data from the Phase HERIZON-BTC-01 trial will be presented at the upcoming . Additionally, the global, open-label, randomized HERIZON-BTC-302 Phase 3 trial ( ) to evaluate the efficacy and safety of zanidatamab in combination with standard-of-care therapy against standard-of-care.
