OPDIVO
Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of several types of cancer, including melanoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma, and renal cell carcinoma. It is used in both adult and pediatric patients (12 years and older) for specific melanoma indications and in adult patients for various stages of NSCLC and other advanced malignancies. Depending on the specific diagnosis and disease stage, the drug is administered as a single agent or in combination with other therapies, such as ipilimumab or platinum-doublet chemotherapy.
How OPDIVO Works
Nivolumab is a monoclonal antibody that binds to the PD-1 receptor on T cells, blocking its interaction with the ligands PD-L1 and PD-L2. This interaction normally inhibits T-cell proliferation and cytokine production, a pathway that tumors can exploit to evade immune surveillance. By blocking this inhibitory signaling, nivolumab releases the immune system's suppression and enhances the anti-tumor immune response. When used in combination with the anti-CTLA-4 antibody ipilimumab, the dual blockade results in increased T-cell function and improved anti-tumor activity.
Details
- Status
- Prescription
- First Approved
- 2014-12-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OPDIVO Approval History
What OPDIVO Treats
11 indicationsOPDIVO is approved for 11 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Non-Small Cell Lung Cancer
- Renal Cell Carcinoma
- Classical Hodgkin Lymphoma
- Head and Neck Cancer
- Urothelial Carcinoma
- Colorectal Cancer
- Hepatocellular Carcinoma
OPDIVO Target & Pathway
ProTarget
An immune checkpoint receptor on T-cells that acts as an 'off switch' for immune responses. Cancer cells often exploit PD-1 by expressing its ligands (PD-L1/PD-L2), allowing tumors to evade immune detection. Blocking PD-1 releases this brake, enabling T-cells to recognize and attack cancer cells.
Pathway Context
PD-1 on T-cells binds to PD-L1/PD-L2 on tumor cells, suppressing immune attack
A protein expressed on tumor cells and immune cells that binds to PD-1 on T-cells, suppressing immune responses. Many cancers overexpress PD-L1 to avoid immune attack. Blocking PD-L1 prevents this immune suppression, allowing the body's T-cells to fight cancer.
A second ligand for PD-1, expressed on antigen-presenting cells and some tumors. PD-L2 binds PD-1 with higher affinity than PD-L1 but is less widely expressed. Drugs blocking PD-1 prevent both PD-L1 and PD-L2 interactions.
OPDIVO Competitors
Pro10 other drugs also target PD-1. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (PD-1). Earlier expiry dates signal biosimilar/generic opportunities.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OPDIVO FDA Label Details
ProIndications & Usage
FDA Label (PDF)OPDIVO is a programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of: Melanoma • adult and pediatric (12 years and older) patients with unresectable or metastatic melanoma, as a single agent or in combination with ipilimumab. • for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. Non-Small Cell Lung Cancer (NSCLC) • adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer in the neoadjuvant setting, in combination with platinum-dou...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.