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EU-authorized Nivolumab
Nivolumab is a monoclonal antibody that blocks PD-1 on T cells, preventing tumor cells from evading immune attack.
Nivolumab is a monoclonal antibody that blocks PD-1 on T cells, preventing tumor cells from evading immune attack. Used for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Renal cell carcinoma (RCC).
At a glance
| Generic name | EU-authorized Nivolumab |
|---|---|
| Also known as | OPDIVO® |
| Sponsor | Amgen |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Nivolumab binds to programmed death receptor-1 (PD-1) on the surface of T cells, blocking interaction with its ligands (PD-L1 and PD-L2) expressed on tumor cells and immune cells. This blockade restores T-cell activation, proliferation, and anti-tumor immune response. By releasing the 'brakes' on the immune system, nivolumab enables the body's own T cells to recognize and destroy cancer cells.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma (RCC)
- Classical Hodgkin lymphoma
- Squamous cell carcinoma of the head and neck
- Colorectal cancer (microsatellite instability-high or mismatch repair deficient)
- Gastric cancer
- Hepatocellular carcinoma
- Mesothelioma
Common side effects
- Fatigue
- Diarrhea
- Nausea
- Rash
- Pruritus
- Immune-mediated pneumonitis
- Immune-mediated hepatitis
- Immune-mediated colitis
- Immune-mediated endocrinopathy (thyroiditis, adrenalitis)
Key clinical trials
- A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma (PHASE3)
- Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy® (PHASE3)
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:
- EU-authorized Nivolumab CI brief — competitive landscape report
- EU-authorized Nivolumab updates RSS · CI watch RSS
- Amgen portfolio CI