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EU-Opdivo®
EU-Opdivo® is a PD-1 checkpoint inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses.
EU-Opdivo® is a PD-1 checkpoint inhibitor that blocks the interaction between PD-1 on T cells and PD-L1/PD-L2 on tumor cells, thereby restoring anti-tumor immune responses. Used for Metastatic non-small cell lung cancer, Melanoma, Renal cell carcinoma.
At a glance
| Generic name | EU-Opdivo® |
|---|---|
| Sponsor | mAbxience Research S.L. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting the PD-1 pathway, the drug removes a key immune checkpoint that tumors exploit to evade T cell-mediated killing. This allows cytotoxic T lymphocytes to recognize and attack cancer cells more effectively. The mechanism has demonstrated clinical benefit across multiple solid and hematologic malignancies.
Approved indications
- Metastatic non-small cell lung cancer
- Melanoma
- Renal cell carcinoma
- Hodgkin lymphoma
- Head and neck squamous cell carcinoma
Common side effects
- Fatigue
- Nausea
- Decreased appetite
- Diarrhea
- Immune-mediated pneumonitis
- Immune-mediated hepatitis
- Immune-mediated colitis
Key clinical trials
- A Study to Evaluate Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Resected Melanoma (PHASE3)
- 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)
- 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)
- Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma (PHASE3)
- 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)
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-Opdivo® CI brief — competitive landscape report
- EU-Opdivo® updates RSS · CI watch RSS
- mAbxience Research S.L. portfolio CI