Vyloy (zolbetuximab) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Astellas Pharma Europe B.V. Vyloy (zolbetuximab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf. Revised September 2024. Accessed October 20, 2024.

Regulatory approvals

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

Indication	Statements
Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	CLDN18.2 >= 75%, HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Fluorouracil, Oxaliplatin, Zolbetuximab
EMA (1)	CLDN18.2 >= 75%, HER2-negative	Adenocarcinoma of the Gastroesophageal Junction	Capecitabine, Oxaliplatin, Zolbetuximab