Overview

Generic Name(s):
naxitamab-gqgk
Trade Name(s):
Danyelza
NCI Definition [1]:
A humanized monoclonal antibody directed against the human tumor-associated antigen GD2, with potential antineoplastic activity. Upon vaccination, naxitamab stimulates antibody-dependent cell-mediated cytotoxicity (ADCC) against GD2-expressing tumor cells. GD2, a disialoganglioside with expression in normal tissues restricted primarily to the cerebellum and peripheral nerves, is commonly expressed at high levels on tumors of neuroectodermal origins such as melanomas and neuroblastomas. Compared to the murine monoclonal antibody 3F8 (m3F8), the humanized form does not cause a human anti-mouse antibody (HAMA) response and shows enhanced ADCC activity.

Naxitamab has been investigated in 8 clinical trials, of which 8 are open and 0 are closed. Of the trials investigating naxitamab, 1 is early phase 1 (1 open), 2 are phase 1 (2 open), 1 is phase 1/phase 2 (1 open), and 4 are phase 2 (4 open).

Ganglioside GD2 Positive and MYCN Amplification are the most frequent biomarker inclusion criteria for naxitamab clinical trials.

Neuroblastoma, osteosarcoma, and desmoplastic small round cell tumor are the most common diseases being investigated in naxitamab clinical trials [2].

Top Biomarker Inclusion Criteria for Open Clinical Trials Investigating Naxitamab
This graph displays the 20 most frequently occurring biomarkers curated on clinical trials investigating naxitamab and the cancer types associated with these biomarkers. These numbers are derived from a set of 5,956 clinical trials for which biomarker status defines treatment.

Drug Details

Synonyms [2]:
humanized monoclonal antibody hu3f8-igg1, hu3f8, humanized anti-gd2 antibody 3f8, naxitamab-gqgk, Danyelza, anti-gd2 igg3 monoclonal antibody 3f8 humanized
Drug Target(s) [2]:
B4GALNT1
NCIT ID [1]:
C123428

References

1. National Cancer Institute. NCI Thesaurus Version 18.11d. https://ncit.nci.nih.gov/ncitbrowser/. [2018-07-30] [2018-08-02].

2. All assertions and clinical trial landscape data are curated from primary sources. You can read more about the curation process here.