zenocutuzumab-zbco

　　【Indications】

　　BIZENGRI is a bispecific antibody directed against HER2 and HER3,indicated for adults with advanced,unresectable,or metastatic tumors confirmed to harbor a neuregulin 1(NRG1)gene fusion and with disease progression on or after prior systemic therapy:

　　•Non-small cell lung cancer(NSCLC):adult advanced,unresectable,or metastatic NRG1 fusion-positive disease with prior systemic progression.

　　•Pancreatic adenocarcinoma:adult advanced,unresectable,or metastatic NRG1 fusion-positive disease with prior systemic progression.

　　•Cholangiocarcinoma:adult advanced,unresectable,or metastatic NRG1 fusion-positive disease with prior systemic progression.

　　【Recommended Dosage】

　　•Select patients based on confirmed NRG1 gene fusion in tumor tissue.

　　•Assess left ventricular ejection fraction(LVEF)before starting BIZENGRI;monitor cardiac function during treatment as clinically indicated.

　　•Recommended regimen is 750 mg by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity.

　　•Administer premedication before each infusion to reduce the risk of infusion-related reactions.

　　•After dilution,give as an intravenous infusion over approximately 4 hours.

　　【Adverse Reactions】

　　•Adverse reactions occurring in≥10%of patients include diarrhea,musculoskeletal pain,fatigue,nausea,infusion-related reactions,dyspnea,rash,constipation,vomiting,abdominal pain,and edema.

　　•Grade 3 or 4 laboratory abnormalities occurring in≥2%include increased GGT,decreased hemoglobin,decreased sodium,decreased platelets,increased AST,increased ALT,increased alkaline phosphatase,decreased magnesium,decreased phosphate,increased aPTT,and increased bilirubin.

　　【Mechanism of Action】

　　Zenocutuzumab-zbco binds the extracellular domains of HER2 and HER3 expressed on tumor and other cells,inhibits HER2:HER3 dimerization,and prevents NRG1 from binding HER3.This reduces signaling through the phosphoinositide 3-kinase(PI3K)-AKT-mammalian target of rapamycin(mTOR)pathway and decreases proliferative signaling.The molecule also mediates antibody-dependent cellular cytotoxicity(ADCC).Antitumor activity has been observed in NRG1 fusion-positive lung and pancreatic cancer models.

　　【Storage】

　　Store in the original carton,protected from light,in a refrigerator at 2°C to 8°C(36°F to 46°F).Do not freeze.Do not shake.