Regulatory approval

Published by the European Medicines Agency.

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.

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