Drug intelligence / Profile preview

dinutuximab beta + isotretinoin

Development stage
Phase 2
Lead developer
Recordati
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous, Oral
01

Overview

Dinutuximab beta plus isotretinoin is a combination regimen used as maintenance therapy (immunotherapy combined with differentiation therapy) for pediatric patients aged one year and above with high-risk neuroblastoma. Dinutuximab beta is a chimeric monoclonal IgG1 antibody produced in Chinese hamster ovary (CHO) cells that targets the disialoganglioside GD2, which is highly expressed on neuroblastoma cells. Upon binding, it triggers tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Isotretinoin (13-cis-retinoic acid) is an oral retinoid that acts as a differentiation therapy, inducing cell cycle arrest and apoptosis in remaining neuroblastoma cells to reduce minimal residual disease. The combination was studied in the SIOPEN HR-NBL1 trial and is recommended as a standard of care for high-risk neuroblastoma.

Other names
dinutuximab beta + 13-cis-RAdinutuximab beta + 13-cis-retinoic aciddinutuximab beta + 13-RAdinutuximab beta + isotretinoindinutuximab beta and 13-cis-retinoic aciddinutuximab beta and isotretinoin
02

Targets

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