VYLOY
Vyloy (zolbetuximab-clzb) is a claudin 18.2-directed cytolytic antibody indicated for the first-line treatment of adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. It is used specifically for patients whose tumors are human epidermal growth factor receptor 2 (HER2)-negative and claudin (CLDN) 18.2 positive as determined by an FDA-approved test. The medication is administered in combination with fluoropyrimidine- and platinum-containing chemotherapy.
How VYLOY Works
Zolbetuximab-clzb is a cytolytic antibody that targets claudin 18.2 (CLDN18.2) on the surface of tumor cells. It depletes these CLDN18.2-positive cells by triggering antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Research in tumor models indicates that combining zolbetuximab-clzb with chemotherapy results in greater antitumor activity than using either agent individually.
Details
- Status
- Prescription
- First Approved
- 2024-10-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VYLOY Approval History
What VYLOY Treats
2 indicationsVYLOY is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VYLOY FDA Label Details
ProIndications & Usage
FDA Label (PDF)VYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)‑negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test [see Dosage and Administration and Clinical Studies ]. VYLOY is a claudin 18.2-directed cytolytic antibody and is indicated in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.