In combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are Claudin-18 protein 2 (CLDN18.2) positive, as determined by an FDA-approved test.
Cycle 1: 800 mg/m² IV over 3 hours. Subsequent cycles: 600 mg/m² IV over 2 hours, every 3 weeks. Administer pre-medications (corticosteroid, antihistamine, antipyretic) before each dose. Administer zolbetuximab before chemotherapy on Day 1.
Concentrate for solution for infusion: 100 mg/10 mL (10 mg/mL) vial
None established in prescribing information.
Nausea (83%), Vomiting (67%), Decreased appetite (46%), Fatigue (30%), Neutropenia (31%), Diarrhea (16%), Constipation (17%), Peripheral neuropathy (11%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
No formal drug interaction studies conducted. As a monoclonal antibody, significant PK drug-drug interactions are not anticipated.
Can cause fetal harm. Advise females of reproductive potential to use effective contraception. Consult the full prescribing information for pregnancy risk details.
Advise women not to breastfeed during treatment and for a period after the last dose. Refer to prescribing information for duration guidance.
Safety and effectiveness in pediatric patients have not been established unless otherwise noted in the full prescribing information.
Dose modifications for organ impairment are specified in the complete prescribing information.
Zolbetuximab is a chimeric IgG1 monoclonal antibody that binds to Claudin-18 isoform 2 (CLDN18.2), a tight junction protein overexpressed in gastric and GEJ adenocarcinomas. Binding leads to antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), resulting in tumor cell lysis. CLDN18.2 is accessible on tumor cells due to disrupted tight junctions.
Route: IV. Vd: ~3.5 L. Protein binding: minimal (monoclonal antibody). Metabolized by proteolytic catabolism. Half-life: ~12 days. Elimination: protein catabolism pathways.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Vyloy has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Vyloy (zolbetuximab) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.
Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.
Zolbetuximab is a chimeric IgG1 monoclonal antibody that binds to Claudin-18 isoform 2 (CLDN18.2), a tight junction protein overexpressed in gastric and GEJ adenocarcinomas. Binding leads to antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), resulting in tum
Nausea (83%), Vomiting (67%), Decreased appetite (46%), Fatigue (30%), Neutropenia (31%), Diarrhea (16%), Constipation (17%), Peripheral neuropathy (11%)