Zanidatamab Receives Priority Review for HER2-Positive Advanced Biliary Tract Cancer

Jazz Pharmaceuticals plc has reported that the Biologics License Application for zanidatamab, a HER2-targeted bispecific antibody, has been accepted and given Priority Review status by the U.S. Food and Drug Administration. This application pertains to the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer. In accordance with the Prescription Drug User Fee Act, the FDA has designated November 29, 2024, as the target date for their decision.

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"The priority review status granted to zanidatamab highlights the urgent need for new therapeutic options for patients with locally advanced or metastatic HER2-positive biliary tract cancer (BTC), a serious condition with a poor outcome," stated Rob Iannone, M.D., M.S.C.E., executive vice president and global head of research and development at Jazz Pharmaceuticals. 

"Should it receive approval, zanidatamab will be the inaugural HER2-directed treatment approved specifically for these patients, and we are eager for the chance to provide this novel therapy to the BTC community," Rob Iannone further commented.

Jazz's Biologics License Application (BLA) is supported by data from Cohort 1 of the Phase 2b HERIZON-BTC-01 trial, which evaluated zanidatamab in patients with unresectable, locally advanced, or metastatic HER2-positive BTC who had received prior treatments. Updated overall survival, duration of response, and additional long-term follow-up results from the Phase 2b HERIZON-BTC-01 trial are set to be disclosed at the upcoming ASCO Annual Meeting 2024.

Moreover, the global, open-label, randomized HERIZON-BTC-302 Phase 3 trial is currently recruiting participants to compare zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone as a first-line treatment for advanced or metastatic HER2-positive BTC. HERIZON-BTC-302 aims to serve as the confirmatory study for zanidatamab in BTC. 

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According to the data provided by the Synapse Database, As of June 6, 2024, there are 625 investigational drugs for the HER2 target, including 328 indications, 628 R&D institutions involved, with related clinical trials reaching 3491, and as many as 73808 patents.

Zanidatamab is an investigational HER2-targeted bispecific antibody that can simultaneously bind two non-overlapping epitopes of the HER2 receptor. Zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.