In this article, we will discuss Naxitamab (Mechanism of Action). So, let’s get started.
Mechanism of Action
Naxitamab-gqgk binds to the glycolipid GD2. GD2 is a disialoganglioside that is overexpressed on neuroblastoma
cells and other cells of neuroectodermal origin, including the central nervous system and peripheral nerves. In vitro, naxitamab-gqgk was able to bind to cell surface GD2 and induce complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC).
Pharmacodynamics
The exposure-response relationship and time course of pharmacodynamic response for the safety and effectiveness of naxitamab-gqgk have not been fully characterized.
Pharmacokinetics
The geometric mean (CV%) maximum plasma concentration (Cmax) of naxitamab-gqgk was 57.4 μg/mL (49%)
following Naxitamab 3 mg/kg intravenous infusion over 30 minutes.
Elimination
The mean terminal half-life of naxitamab-gqgk was 8.2 days.
Metabolism
Naxitamab-gqgk is expected to be metabolized into small peptides by catabolic pathways.
Specific Populations
Population pharmacokinetic analyses suggest that age (range: 1 to 34 years), sex and race have no clinically important effect on the clearance (CL) of naxitamab-gqgk. The naxitamab-gqgk systemic exposure (AUC) at 150 mg/day (450 mg per cycle) for patients with body weight over 50 kg is not expected to differ clinically from that of the naxitamab-gqgk exposures at 3 mg/kg/day (9 mg/kg per cycle) for patients with body weight of 30 – 50 kg.