OPDUALAG
OPDUALAG is a combination of nivolumab and relatlimab indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. This therapy combines two different immune checkpoint inhibitors to address advanced melanoma that cannot be removed by surgery or has spread to other parts of the body. By utilizing two distinct monoclonal antibodies, the treatment provides a dual-pathway approach to enhancing the body's immune response against tumor cells.
How OPDUALAG Works
OPDUALAG functions by blocking two separate pathways that inhibit T-cell activation, thereby enhancing the immune system's anti-tumor response. Relatlimab binds to the LAG-3 receptor to prevent inhibitory signaling and promote T-cell proliferation, while nivolumab binds to the PD-1 receptor to block ligands that tumors use to evade immune surveillance. Together, these antibodies increase T-cell activation and cytokine secretion more effectively than either agent alone, leading to inhibited tumor growth and promoted tumor regression.
Details
- Status
- Prescription
- First Approved
- 2022-03-18
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
OPDUALAG Approval History
What OPDUALAG Treats
2 indicationsOPDUALAG is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable melanoma
- Metastatic melanoma
OPDUALAG 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.
OPDUALAG 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.
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.
OPDUALAG FDA Label Details
ProIndications & Usage
FDA Label (PDF)OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. OPDUALAG is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.