zolbetuximab

　　【Indications】

VYLOY (zolbetuximab-clzb) is a claudin 18.2 (CLDN18.2)-targeting cytolytic antibody. It is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.

【Recommended Dosage】

• Administer only as an intravenous infusion. Do not administer as an intravenous push or bolus.

• The recommended initial dose is 800 mg/m², followed by maintenance doses of either:

  • 600 mg/m² every 3 weeks; or

  • 400 mg/m² every 2 weeks.

【Adverse Reactions】

The most common adverse reactions (≥15%) when used in combination with mFOLFOX6 or CAPOX regimen were nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, weight decreased, hypersensitivity reactions, and pyrexia.

The most common laboratory abnormalities (≥15%) were decreased neutrophil count, decreased white blood cell count, decreased albumin, increased creatinine, decreased hemoglobin, increased glucose, decreased lymphocyte count, increased aspartate aminotransferase, decreased platelets, increased alkaline phosphatase, increased alanine aminotransferase, decreased glucose, decreased sodium, increased phosphate, decreased potassium, and decreased magnesium.

【Pharmacological Action】

Zolbetuximab-clzb is a cytolytic antibody that targets claudin 18.2 (CLDN18.2). It depletes CLDN18.2-positive cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). In mouse tumor models expressing CLDN18.2, zolbetuximab-clzb in combination with chemotherapy demonstrated greater antitumor activity compared to zolbetuximab-clzb or chemotherapy alone.

【Storage】

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