AMERICAN SOCIETY OF CLINICAL ONCOLOGY

Jazz Pharmaceuticals completes BLA submission for zanidatamab, a HER2-targeted bispecific antibody, seeking accelerated approval for treatment of previously-treated HER2-positive metastatic biliary tract cancer. If approved, zanidatamab would be the first HER2-targeted treatment for this indication in the U.S. The BLA includes data from the Phase 2b HERIZON-BTC-01 trial showing a confirmed objective response rate of 41.3% in HER2-positive BTC patients, with a manageable safety profile.