Vyloy
Vyloy ingredients
| Active ingredient | Strength |
|---|---|
| Zolbetuximab | 20 mg/mL |
What Vyloy is used for
The FDA lists the approved uses on the official label (below). In the EU, zolbetuximab is approved as Vyloy 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).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Vyloy
- Generic name
- Zolbetuximab
- Made by
- Astellas Pharma US, Inc.
- Forms
- Injection, Powder, For Suspension
- Given
- Intravenous
- Drug class
- Claudin 18.2-directed Cytolytic Antibody
- FDA approval
- Biologic licence (BLA) BLA761365
- On the US market since
- 2024
Official information
- Vyloy prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Zolbetuximab)
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?
Vyloy (Zolbetuximab) is a cancer medicine made by Astellas Pharma US, Inc., approved by the US FDA.
What are the ingredients of Vyloy?
Vyloy contains Zolbetuximab (20 mg/mL).
Is Vyloy approved in Europe?
The same active substance is approved in the EU as Vyloy.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA