Vyloy
What Vyloy is used for
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).
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Vyloy
- Active substance
- zolbetuximab
- Disease area
- Stomach Neoplasms; Esophageal Neoplasms
- ATC code
- L01FX31
- Marketing authorisation holder
- Astellas Pharma Europe B.V.
- Authorised in the EU since
- 2024
Official information
In the USA
Same active substance: Vyloy
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Vyloy used for?
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).
What is the active substance in Vyloy?
Vyloy contains zolbetuximab.
Who makes Vyloy?
The EU marketing authorisation holder is Astellas Pharma Europe B.V..
Is Vyloy an orphan medicine?
Yes. Vyloy is designated an orphan medicine in the EU, for a rare disease (Stomach Neoplasms; Esophageal Neoplasms).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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