OPDIVO
PeakmAbBLAINJECTIONINJECTABLEPriority Review
Approved
Mar 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
OPDIVO by Bristol Myers Squibb is pd-1 ligands, pd-l1 and pd-l2, to the pd-1 receptor found on t cells, inhibits t-cell proliferation and cytokine production. First approved in 2015.
Drug data last refreshed 8h ago · AI intelligence enriched 1mo 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 enhance anti-tumor T-cell responses. It is indicated for multiple solid tumors and hematologic malignancies where PD-L1/PD-L2 upregulation contributes to immune evasion. The drug can be used as monotherapy or in combination with ipilimumab (anti-CTLA-4) for enhanced immune activation.
$0.051BPart D
PeakAs a peak-lifecycle immunotherapy, OPDIVO supports a large, mature commercial organization with established field and brand teams managing competitive market dynamics.
Mechanism of Action
PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab…
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 Sep 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.