Overview
Nivolumab is a fully human IgG4 antibody targeting the immune checkpoint programmed death receptor-1 (PD-1). This antibody was produced entirely in mice and grafted onto human kappa and IgG4 Fc region with the mutation S228P for additional stability and reduced variability. It was developed by Bristol Myers Squibb. Nivolumab was granted FDA approval on 22 December 2014.
Indication
Nivolumab is indicated to treat unresectable or metastatic melanoma, melanoma as adjuvant treatment, resectable or metastatic non-small cell lung cancer, small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of the head and neck, urothelial carcinoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, hepatocellular carcinoma, and esophageal cancer. The indication for classical Hodgkin lymphoma, microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer, and hepatocellular carcinoma were approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Nivolumab is also approved for the treatment of HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma when used in combination with a fluoropyrimidine- and platinum-containing chemotherapy regimen. In combination with relatlimab, nivolumab is indicated for the treatment of patients ≥12 years old with unresectable or metastatic melanoma.
Associated Conditions
- Advanced Esophageal Adenocarcinoma
- Advanced Gastric Adenocarcinoma
- Advanced Gastric Carcinoma
- Advanced Gastroesophageal Junction Adenocarcinoma
- Advanced Renal Cell Carcinoma
- Classical Hodgkin's Lymphoma
- Completely resected Stage IIB melanoma
- Completely resected Stage III melanoma
- Completely resected Stage IV melanoma
- Hepatocellular Carcinoma
- Locally Advanced Hepatocellular Carcinoma
- Locally Advanced Non-Small Cell Lung Cancer
- Melanoma
- Metastatic Colorectal Cancer (CRC)
- Metastatic Esophageal Adenocarcinoma
- Metastatic Esophageal Squamous Cell Carcinoma
- Metastatic Gastric Adenocarcinoma
- Metastatic Gastric Cancers
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Metastatic Hepatocellular Carcinoma
- Metastatic Melanoma
- Metastatic Non-Small Cell Lung Cancer
- Metastatic Renal Cell Carcinoma ( mRCC)
- Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
- Metastatic Urothelial Carcinoma (UC)
- Mismatch Repair-deficient (dMMR) Metastatic Colorectal Cancer (CRC)
- Muscle-invasive Urothelial Carcinoma
- Poor Risk Advanced Renal Cell Cancer
- Recurrent Non-small Cell Lung Cancer
- Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- Relapsed or Refractory Classical Hodgkin's Lymphoma
- Resectable Non-small Cell Lung Cancer
- Stage IIB Melanoma
- Stage IIC Melanoma
- Unresectable Esophageal Squamous Cell Carcinoma
- Unresectable Locally Advanced Urothelial Cancer
- Unresectable Melanoma
- Urothelial Carcinoma
- Completely resected Stage IIC melanoma
- Intermediate risk Advanced Renal Cell Cancer
- Locally advanced Urothelial Carcinoma
- Metastatic Microsatellite Instability High Colorectal Cancer
- Metastatic Mismatch Repair Deficient Colorectal Cancer
- Metastatic gastroesphageal juntion adenocarcinoma
- Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Relapsed Classical Hodgkin's Lymphoma
- Residual Esophageal Cancer
- Residual Gastroesophageal Junction Cancer
- Unresectable Malignant Pleural Mesothelioma (MPM)
- Unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
- Unresectable, advanced Esophageal Squamous Cell Carcinoma (ESCC)
- Unresectable, metastatic Esophageal Squamous Cell Carcinoma (ESCC)
- Unresectable, recurrent Esophageal Squamous Cell Carcinoma (ESCC)
Research Report
A Comprehensive Monograph on Nivolumab (Opdivo®): Pharmacology, Clinical Efficacy, and Therapeutic Landscape
Executive Summary & Drug Profile
Overview of Nivolumab
Nivolumab represents a cornerstone of modern immuno-oncology, a therapeutic class that has fundamentally altered the treatment paradigm for a multitude of malignancies. Marketed under the brand name Opdivo®, Nivolumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody developed by Bristol Myers Squibb.[1] It functions as an immune checkpoint inhibitor by selectively targeting the programmed death receptor-1 (PD-1).[2] First granted approval by the U.S. Food and Drug Administration (FDA) in December 2014, Nivolumab was a pioneering agent in its class and has since garnered approvals for an exceptionally broad range of solid tumors and hematologic cancers.[4]
The therapeutic principle of Nivolumab is not to attack cancer cells directly, but to block a key inhibitory signal used by tumors to evade the host immune system. By binding to the PD-1 receptor on T-cells, Nivolumab prevents their deactivation, thereby unleashing a patient's own T-cells to recognize and eliminate malignant cells.[2] This mechanism has led to durable, long-term responses and significant improvements in overall survival in cancers that were previously considered difficult to treat. However, this potentiation of the immune system is also responsible for a unique and characteristic spectrum of immune-related adverse events (irAEs), which require specialized clinical management.[4] The drug's development and expanding applications, both as a monotherapy and in combination with other agents like the CTLA-4 inhibitor ipilimumab, underscore its central role in the contemporary oncologic armamentarium.
Core Drug Identification and Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/03 | Not Applicable | Recruiting | |||
2025/07/30 | N/A | Not yet recruiting | Beatrice Castellani | ||
2025/07/29 | N/A | Not yet recruiting | |||
2025/07/23 | N/A | Completed | |||
2025/06/22 | Phase 1 | Recruiting | |||
2025/06/17 | N/A | Active, not recruiting | |||
2025/06/12 | Early Phase 1 | Not yet recruiting | Children's National Research Institute | ||
2025/06/10 | Phase 2 | Not yet recruiting | |||
2025/06/09 | Phase 2 | Not yet recruiting | |||
2025/06/02 | Phase 3 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| E.R. Squibb & Sons, L.L.C. | 0003-3772 | INTRAVENOUS | 10 mg in 1 mL | 8/30/2021 | |
| E.R. Squibb & Sons, L.L.C. | 0003-7125 | INTRAVENOUS | 12 mg in 1 mL | 3/18/2022 | |
| E.R. Squibb & Sons, L.L.C. | 0003-3756 | INTRAVENOUS | 10 mg in 1 mL | 8/30/2021 | |
| E.R. Squibb & Sons, L.L.C. | 0003-3734 | INTRAVENOUS | 10 mg in 1 mL | 8/30/2021 | |
| E.R. Squibb & Sons, L.L.C. | 0003-3774 | INTRAVENOUS | 10 mg in 1 mL | 8/30/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/15/2022 | ||
Authorised | 6/19/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NIVOLUMAB BMS CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML | SIN15117P | INFUSION, SOLUTION CONCENTRATE | 10 mg/mL | 11/9/2016 | |
| OPDUALAG CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/80MG | SIN16852P | INFUSION, SOLUTION CONCENTRATE | 240mg per vial | 8/31/2023 | |
| OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML | SIN14975P | INFUSION, SOLUTION CONCENTRATE | 10mg/mL | 4/4/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 40MG/4ML | N/A | N/A | N/A | 12/22/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| OPDIVO nivolumab 100 mg in 10 mL (10 mg/mL) concentrated solution for IV infusion vial | 231868 | Medicine | A | 1/11/2016 | |
| OPDIVO nivolumab 40 mg in 4 mL (10 mg/mL) concentrated solution for IV infusion vial | 231867 | Medicine | A | 1/11/2016 | |
| OPDUALAG nivolumab 240mg and relatlimab 80mg in 20mL concentrate solution for IV infusion vial | 372783 | Medicine | A | 10/7/2022 | |
| OPDIVO nivolumab 240 mg in 24 mL (10 mg/mL) concentrate solution for IV infusion vial | 318057 | Medicine | A | 4/9/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OPDUALAG | bristol-myers squibb canada | 02541416 | Solution - Intravenous | 240 MG / 20 ML | 2/12/2024 |
| OPDIVO | bristol-myers squibb canada | 02446626 | Solution - Intravenous | 10 MG / ML | 10/23/2015 |
| OPDIVO SC | bristol-myers squibb canada | 02557320 | Solution - Subcutaneous | 120 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1151014002IP | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1151014001IP1 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1151014001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1151014002 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1151014001IP | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| OPDIVO 600 MG SOLUCION INYECTABLE | 1151014005 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCION PARA PERFUSION | 1151014002IP1 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| OPDUALAG 240 MG/80 MG CONCENTRADO PARA SOLUCION PARA PERFUSION | 1221679001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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