Vyloy (zolbetuximab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Astellas Pharma Canada, Inc. Vyloy (zolbetuximab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078035.PDF. Published December 2024. Accessed June 2025.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Vyloy (zolbetuximab for injection), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive as determined by a validated test. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) CLDN18.2 >= 75%, HER2-negative Adenocarcinoma of the Gastroesophageal Junction Capecitabine, Oxaliplatin, Zolbetuximab