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US-sourced YERVOY®
YERVOY is a monoclonal antibody that blocks the PD-1 receptor, allowing the immune system to attack cancer cells.
YERVOY is a monoclonal antibody that blocks the PD-1 receptor, allowing the immune system to attack cancer cells. Used for Metastatic melanoma, Adenocarcinoma of the microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, Colorectal cancer.
At a glance
| Generic name | US-sourced YERVOY® |
|---|---|
| Sponsor | Shanghai Henlius Biotech |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, YERVOY prevents the PD-1 ligands (PD-L1 and PD-L2) from interacting with PD-1, thereby releasing the brakes on the immune system and allowing it to attack cancer cells. This mechanism is thought to be responsible for the anti-tumor activity of YERVOY.
Approved indications
- Metastatic melanoma
- Adenocarcinoma of the microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
- Colorectal cancer
- Renal cell carcinoma
- Head and neck squamous cell carcinoma
- Hepatocellular carcinoma
- Non-small cell lung cancer
- Urothelial carcinoma
Common side effects
- Fatigue
- Pruritus
- Diarrhea
- Nausea
- Rash
- Hypothyroidism
- Decreased appetite
- Weight loss
- Arthralgia
- Musculoskeletal pain
Key clinical trials
- Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma (PHASE1)
- A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma (PHASE3)
- A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects (PHASE1)
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:
- US-sourced YERVOY® CI brief — competitive landscape report
- US-sourced YERVOY® updates RSS · CI watch RSS
- Shanghai Henlius Biotech portfolio CI