Naxitamab (Danyelza)
General information
Class/mechanism: glycolipid GD2 recombinant humanized monoclonal IgG1 antibody. Naxitamab-gqgk binds to the glycolipid GD2, which is overexpressed on neuroblastoma cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, binding resulted in complement dependent cytotoxicity (CDC) and antibody dependent cell-mediated cytotoxicity (ADCC).[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2020-11-24: FDA accelerated approval to be used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy. (Based on Study 12-230 & Study 201)
Also known as
- Generic name: naxitamab-gqgk
- Brand name: Danyelza