Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized zolbetuximab 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) adenocracinoma whose tumors are Claudin (CLDN) 18.2 positive. The product information states that eligible patients should have CLDN18.2 positive tumor defined as >= 75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, assessed by a CE-marked IVD with the corresponding intended purpose. The product information further states that this indication is based on Spotlight (8951-CL-0301) and Glow (8951-CL-0302), both phase 3, double-blind, randomized, multicenter studies that enrolled 1072 patients where the choice of either mFOLFOX6 (oxaliplatin, folinic acid, and fluorouracil) or CAPOX (oxaliplatin and capecitabine).

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2024-09-19	European Medicines Agency	Indication received approval from the European Commission.