FDA grants Breakthrough Therapy Designation to epcoritamab-bysp

FDA accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The phase III HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.