DINUTUXIMAB
Drug Details
- Generic Name
- DINUTUXIMAB
- Brand Names
- Unituxin
- Application Number
- BLA125516
- Sponsor
- United Therapeutics Corporation
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- DINUTUXIMAB
Indications and Usage
1 INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. ( 1 )