U.S. License Holder:
Y-Mabs Therapeutics Inc.
Date of License:
November-25-2020
Last Update:
Sep-30-2024
FDA-Approved Indications
DANYELZA (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.