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VYLOY (ZOLBETUXIMAB-CLZB)
VYLOY (generic name: ZOLBETUXIMAB-CLZB) is a Claudin 18.2-directed Cytolytic Antibody [EPC] drug developed by ASTELLAS. It is currently FDA-approved.
VYLOY is a treatment that combines zolbetuximab, pembrolizumab, and capecitabine for patients with certain types of stomach cancer, including locally advanced unresectable and metastatic gastric adenocarcinoma and gastroesophageal junction (GEJ) adenocarcinoma. This combination treatment is being studied in clinical trials, including NCT06901531, for its potential to improve outcomes in these patients.
At a glance
| Generic name | ZOLBETUXIMAB-CLZB |
|---|---|
| Sponsor | ASTELLAS |
| Drug class | Claudin 18.2-directed Cytolytic Antibody [EPC] |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Nausea
- Vomiting
- Fatigue
- Decreased appetite
- Diarrhea
- Peripheral sensory neuropathy
- Abdominal pain
- Constipation
- Decreased weight
- Hypersensitivity reactions
- Pyrexia
- Decreased neutrophil count
Serious adverse events
- Vomiting
- Nausea
- Intestinal obstruction
- Neutropenia
- Febrile neutropenia
- Diarrhea
- Pyrexia
- Pneumonia
- Respiratory failure
- Pulmonary embolism
Key clinical trials
- A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic (Phase 3)
- Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea (N/A)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VYLOY CI brief — competitive landscape report
- VYLOY updates RSS · CI watch RSS
- ASTELLAS portfolio CI
Frequently asked questions about VYLOY
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Related
- Drug class: All Claudin 18.2-directed Cytolytic Antibody [EPC] drugs
- Manufacturer: ASTELLAS — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing