Zanidatamab-Hrii (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- ZIIHERA
Boxed Warning
Embryo-Fetal Toxicity: Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)].
Indications and Usage
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).
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reactions are described in greater detail in other sections of the labeling: •Embyro-Fetal Toxicity [see Warnings and Precautions (5.1)] •Left Ventricular dysfunction [see Warnings and Precautions (5.2)] •Infusion-Related Reactions [see Warnings and Precautions (5.3)] •Diarrhea [see Warnings and Precautions (5.4)]
Mechanism of Action
Zanidatamab‑hrii is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab‑hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab‑hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.