nivolumab
Opdivo (nivolumab) is a PD-1 checkpoint inhibitor from Bristol-Myers Squibb used across many cancers, including melanoma, lung, kidney, bladder, liver, esophageal and gastric cancers, and Hodgkin lymphoma. By releasing the PD-1 brake on T cells, it restores immune attack on tumours, alone or with combinations.
This page is based on FDA prescribing information and the EMA medicine record for nivolumab, cross-checked with DailyMed and the National Cancer Institute dictionary; the mechanism is explained in plain language, and analogies are used only where they stay accurate.
How it works
Explains what the medicine does in the body, not dosing, side effects, or safety.
An analogy
A tumour waves a molecular white flag that engages the PD-1 brake on passing T cells, so the immune patrol stands down and walks by. Nivolumab covers the brake. T cells can no longer be switched off by the flag, recognise the tumour for what it is, and attack.
In simple terms
T cells are built to destroy abnormal cells, but many cancers protect themselves by displaying ligands PD-L1 and PD-L2, which bind the PD-1 receptor on T cells and turn them off. Nivolumab is a fully human antibody that blocks PD-1, so the tumour can no longer deliver that off signal. Freed from suppression, T cells reactivate and attack cancer cells across the body, which is why the drug works in so many tumour types.
In depth
Nivolumab is a fully human immunoglobulin G4 monoclonal antibody directed against the negative immunoregulatory receptor PD-1. By binding PD-1 it blocks signalling through its ligands PD-L1, which is overexpressed on certain cancer cells, and PD-L2, which is primarily expressed on antigen-presenting cells. Because activated PD-1 negatively regulates T-cell activation and plays a key role in tumour evasion from host immunity, blocking the receptor restores T-cell activation and cell-mediated immune responses against tumour cells. Nivolumab is used as monotherapy or with ipilimumab, chemotherapy, or targeted agents depending on tumour type and line of therapy.
See it in motion
A schematic animation of the mechanism — simplified for clarity, not drawn to scale.
How nivolumab, a fully human IgG4 anti-PD-1, frees T cells across many tumours
- Nivolumab is a fully human immunoglobulin G4 monoclonal antibody directed against the negative immunoregulatory receptor PD-1.
- By binding PD-1 it blocks signalling through its ligands PD-L1, which is overexpressed on certain cancer cells, and PD-L2, which is primarily expressed on antigen-presenting cells.
- blocking the receptor restores T-cell activation and cell-mediated immune responses against tumour cells.
- Nivolumab is used as monotherapy or with ipilimumab, chemotherapy, or targeted agents depending on tumour type and line of therapy.
Target: Programmed death-1 (PD-1) receptor
An off-switch on T cells that cancers exploit through its ligands PD-L1 and PD-L2 to escape immune attack; blocking PD-1 reactivates T cells against the tumour.
Approved uses
Approved uses differ by country and change over time. Always follow your local prescribing information.
Approved uses in United States
FDA- As a single agent or in combination with ipilimumab, for the treatment of adults and pediatric patients 12 years and older with unresectable or metastatic melanoma
- For the adjuvant treatment of adults and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma
- In combination with platinum-doublet chemotherapy as neoadjuvant treatment, and as single-agent adjuvant treatment after surgery, for adults with resectable non-small cell lung cancer with no known EGFR mutations or ALK rearrangements
- In combination with ipilimumab, for the first-line treatment of adults with unresectable malignant pleural mesothelioma
- In combination with ipilimumab, for the first-line treatment of adults with intermediate or poor risk advanced renal cell carcinoma
- In combination with cisplatin and gemcitabine, for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma
- In combination with ipilimumab, for the treatment of adults and pediatric patients 12 years and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer
- In combination with ipilimumab, for the first-line treatment of adults with unresectable or metastatic hepatocellular carcinoma
- For the adjuvant treatment of adults with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy
- In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of adults with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma whose tumors express PD-L1 (1 percent or more)
Approved uses in European Union
EMA- As monotherapy or in combination with ipilimumab, for the treatment of adults and adolescents 12 years of age and older with advanced (unresectable or metastatic) melanoma
- As monotherapy, for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease, who have undergone complete resection
- In combination with ipilimumab and two cycles of platinum-based chemotherapy, for the first-line treatment of adults with metastatic non-small cell lung cancer whose tumours have no sensitising EGFR mutation or ALK translocation
- As monotherapy, for the treatment of adults with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy
- In combination with platinum-based chemotherapy as neoadjuvant treatment, followed by nivolumab monotherapy as adjuvant treatment, for adults with resectable non-small cell lung cancer at high risk of recurrence whose tumours have PD-L1 expression of 1 percent or more
Official sources
The statements on this page trace back to these records.
- Opdivo (nivolumab) — Summary of product characteristics and package leaflet, English version
European Medicines Agency
- DailyMed: OPDIVO (nivolumab) official US label
U.S. National Library of Medicine, DailyMed
- U.S. Food and Drug Administration: nivolumab prescribing information
U.S. Food and Drug Administration
- National Cancer Institute: nivolumab
National Cancer Institute
This page explains how the medicine works — it isn’t the patient leaflet. For anything that applies to you, read the leaflet that came with your medicine or ask your pharmacist.
MedUnfold provides educational content and is not medical advice. Always follow your local prescribing information and healthcare professional.