FDA Approves Ziihera for Biliary Tract Cancer

The U.S. FDA has granted accelerated approval to Jazz Pharmaceuticals' zanidatamab-hrii, branded as Ziihera, for the treatment of HER2-positive biliary tract cancer (BTC). This innovative therapy targets specific molecular markers in previously treated adult patients with unresectable or metastatic BTC, offering a new treatment option where few exist. The approval was based on a 52% objective response rate and a median duration of response of 14.9 months from clinical trials. Jazz's Phase 3 HERIZON-BTC-302 trial is ongoing to confirm clinical benefits in a first-line setting. Ziihera is the first dual HER2-targeted bispecific antibody approved for this indication in the U.S., marking a significant advancement for patients facing a dire prognosis. The drug is also under regulatory review in China and Europe, reflecting its potential global impact.