On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The approval is supported by data from the Phase 3 HERIZON-BTC-01 trial (NCT04466891) which demonstrated a 52% objective response rate and a median duration of response (DOR) of 14.9 months as determined by independent central review.
Jazz Pharmaceuticals says that continued approval of this indication “may be contingent upon verification and description of clinical benefit in a confirmatory trial”.
Zanidatamab is being developed by Jazz and BeiGene under licence agreements from Zymeworks, which first developed the molecule.