Under the Prescription Drug User Fee Act (PDUFA), FDA has set a target action date of
'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
Jazz's BLA submission is based on results from Cohort 1 of the Phase 2b HERIZON-BTC-01 clinical trial (NCT05152147) 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
Additionally, the global, open-label, randomized HERIZON-BTC-302 Phase 3 trial (NCT06282575) to evaluate the efficacy and safety of zanidatamab in combination with standard-of-care therapy against standard-of-care therapy alone in first-line advanced or metastatic HER2-positive BTC is ongoing and is open for enrollment. HERIZON-BTC-302 is expected to serve as the confirmatory trial for zanidatamab in BTC.
About Zanidatamab
Zanidatamab is an investigational HER2-targeted bispecific antibody that can simultaneously bind two non-overlapping epitopes of the HER2 receptor, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by
The
About Biliary Tract Cancer
BTC, including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, account for
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