Zanidatamab: Side Effects, Uses & Monitoring

Labeled uses

ZIIHERA is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test [see Dosage and Administration (2.1 )]. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).