BLAINJECTIONINJECTABLEPriority Review
Approved
Dec 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
OPDIVO (nivolumab) by Bristol Myers Squibb is programmed death receptor-1-directed antibody interactions [moa]. Approved for programmed death receptor-1 blocking antibody [epc]. First approved in 2014.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPDIVO (nivolumab) is a monoclonal antibody that blocks the programmed death receptor-1 (PD-1) checkpoint, allowing the immune system to recognize and attack cancer cells. It is approved for multiple cancer indications including melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin lymphoma. The drug works by releasing the 'brakes' on T-cell-mediated anti-tumor immunity.
$0.051BPart D
PeakPeak-stage mature asset with significant but declining relative market share versus KEYTRUDA; commercial teams focused on indication expansion and price defense rather than market capture.
Mechanism of Action
Programmed Death Receptor-1-directed Antibody Interactions
Pharmacologic Class:
Programmed Death Receptor-1 Blocking Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
Started Feb 2027
600 enrolled
Gastric CancerEsophagogastric Junction CancerEsophageal Adenocarcinoma
iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma
Started Dec 2026
550 enrolled
Melanoma (Skin Cancer)Advanced MelanomaMetastatic Melanoma+1 more
A Study to Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Unresectable or Metastatic Melanoma Participants In India
Started Nov 2026
40 enrolled
Unresectable MelanomaMetastatic Melanoma
Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma
Started Oct 2026
28 enrolled
Unresectable Cutaneous Melanoma
PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma/High-grade Glioma and Recurrent Diffuse Midline Glioma/High-grade Glioma, Medulloblastoma, and Ependymoma
Started Sep 2026
68 enrolled
Diffuse Midline GliomaDiffuse Midline High-grade GliomaMedulloblastoma+1 more
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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.