OPDIVO
PeakmAbBLAINJECTIONINJECTABLEPriority Review
Approved
Mar 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPDIVO (nivolumab) is a human IgG4 monoclonal antibody that blocks PD-1 receptor signaling to release immune checkpoint inhibition and enable T-cell anti-tumor activity. It is approved across multiple solid tumors including melanoma, NSCLC, renal cell carcinoma, hepatocellular carcinoma, colorectal cancer, and esophageal cancer, primarily in combination with ipilimumab. The mechanism restores immune surveillance by preventing tumor-mediated suppression of T-cell proliferation and cytokine production.
$0.051BPart D
PeakOPDIVO is in peak commercial stage with established market presence; teams are focused on maximizing indication penetration and managing competitive erosion rather than rapid growth.
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 (14)
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Started Aug 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
Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig
Started Aug 2025
200 enrolled
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
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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.