Is Zolbetuximab approved by the US FDA?

Drugs@FDA lists 1 application product line for Zolbetuximab, including VYLOY (Prescription).

Is Zolbetuximab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Zolbetuximab: Vyloy.

Are there safety signals or safety updates for Zolbetuximab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-06-11).

Active substance

Zolbetuximab

US FDA 1
EMA 1
Health Canada 2
Safety 3

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VYLOY	100MG	injectable · injection	ASTELLAS	Prescription	18 Oct 2024

EMA European Union — centrally authorised medicines

Vyloy Astellas Pharma Europe B.V. · Authorised · authorised 19 Sep 2024 · ATC L01FX31

Therapeutic indication (EMA)

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 (see section 4.2).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VYLOY	02553996	100 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	ASTELLAS PHARMA CANADA INC
VYLOY	02563916	300 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	ASTELLAS PHARMA CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 11 Jun 2026 PRAC signal: Protein-losing gastroenteropathy
Action for MAH: update of the product information: Yes
EMA PRAC 15 Jan 2026 PRAC signal: Protein-losing gastroenteropathy
Action for MAH: update of the product information: No
US FDA 6 Jun 2025 VYLOY — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for zolbetuximab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.