CHIMERIX, INC. | MedPath

FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer

6 months ago

• The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC). • Approval was based on a 52% objective response rate and a median duration of response of 14.9 months in the HERIZON-BTC-01 trial. • Ziihera is the first dual HER2-targeted bispecific antibody and chemotherapy-free treatment option for patients with HER2-positive BTC. • A confirmatory Phase 3 trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone.