Who can use Ziihera(Zanidatamab)?

This part specifies the approved use of ZIIHERA in a specific patient population.

Approved Use

ZIIHERA is indicated for treating adults with unresectable or metastatic HER2-positive biliary tract cancer, specifically in tumors exhibiting IHC 3+ protein expression as determined by an FDA-approved test. This approval is granted under an accelerated pathway for patients whose disease has progressed following prior systemic therapy that included a gemcitabine-based regimen. Continued approval is contingent on verification of clinical benefit in confirmatory trials.