Drug profile · INN
zolbetuximab-clzb
VYLOY
zolbetuximab-clzb (VYLOY) is a claudin-18 binding agent. Route of administration: injection. Current US regulatory status: approved.
Drug details — zolbetuximab-clzb
- US status
- approved
- Class
- —
- Route
- INJECTION
- Patents
- 0
- Programs
- 0
- Data quality
- 0.84
Quick answer
zolbetuximab-clzb (VYLOY) is a claudin-18 binding agent. Route of administration: injection. Current US regulatory status: approved.
Key facts
Mechanism of action
Claudin-18 binding agent
Primary target: Claudin-18
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
Recent coverage
FDA approves Vyloy for HER2-negative gastric and GEJ cancer
The FDA approved zolbetuximab-clzb (Vyloy) with chemotherapy for gastric and gastroesophageal junction adenocarcinoma on October 18, 2024. Astellas says it is the first and only CLDN18.2-targeted therapy approved in the U.S. for these cancers.
데일리팜 리크루트: Vyloy (zolbetuximab) Reimbursement Progress and Market Implications for Gastric Cancer
Vyloy (zolbetuximab) has passed the HIRA Pharmacoeconomic Evaluation Subcommittee and is set for Drug Reimbursement Evaluation Committee review. This analysis covers the clinical evidence, regulatory milestones, and strategic implications for pharma stakeholders.
Related & competitor drugs
Frequently asked questions
What is zolbetuximab-clzb?
zolbetuximab-clzb (VYLOY) is a claudin-18 binding agent. Route of administration: injection. Current US regulatory status: approved.
What is the brand name for zolbetuximab-clzb?
VYLOY is a marketed brand name for zolbetuximab-clzb. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of zolbetuximab-clzb?
zolbetuximab-clzb has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.