U.S. License Holder:
United Therap.
Date of License:
March-10-2015
Last Update:
Dec-15-2024
FDA-Approved Indications
UNITUXIN (dinutuximab) 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.