The FDA has granted accelerated approval to zanidatamab-hrii, a bispecific antibody targeting HER2, for patients with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer. Approval was based on promising results from clinical trials, which demonstrated significant antitumor activity. This marks a key advancement in targeted therapies for this rare but aggressive cancer type. Further confirmatory trials are underway to validate these findings.