VYLOY (zolbetuximab-clzb)
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
- Patent Cliff
- 2031
- 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
VYLOY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in VYLOY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications VYLOY treats. First-in-class if their pivotal trials read out positive.
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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
Indications & Usage
FDA Label (PDF)VYLOY is indicated for the treatment of Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.