OPDIVO
PeakmAbBLAINJECTIONINJECTABLEPriority Review
Approved
Mar 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPDIVO (nivolumab) is a human IgG4 monoclonal antibody that blocks the PD-1 receptor on T cells, removing immune checkpoint inhibition and enabling anti-tumor immune responses. It is approved for multiple oncology indications including renal cell carcinoma, melanoma, NSCLC, colorectal cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma, primarily in combination with ipilimumab. The drug works by binding to PD-1 and preventing interaction with PD-L1 and PD-L2 ligands, thereby releasing T-cell proliferation and cytokine production previously suppressed by tumor microenvironments. OPDIVO represents a cornerstone immunotherapy in the competitive checkpoint inhibitor landscape and is indicated across multiple solid tumors.
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Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Started Jun 2026
120 enrolled
Melanoma
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
Started Dec 2025
632 enrolled
Advanced (Unresectable or Metastatic) Melanoma
A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
Started Nov 2025
144 enrolled
Colorectal Cancer
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
Started Dec 2024
52 enrolled
Melanoma
Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
Started Mar 2024
392 enrolled
Advanced MelanomaMelanoma (Skin)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.