DOI . ORG {
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Title[redir]:
Dinutuximab: First Global Approval | Drugs
Description:
United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I–III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy.
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Topics {✒️}
granulocyte-macrophage colony-stimulating factor chimeric anti-gd2-antibody ch14 gov/drugs/informationondrugs/approveddrugs/ucm437480 chimeric anti-gd2 antibody 13-cis retinoic acid month download article/chapter gov/drugsatfda_docs/label/2015/125516s000lbl gov/drugsatfda_docs/appletter/2015/125516orig1s000ltr oral metronomic chemotherapy pediatric high-risk neuroblastoma hematopoietic stem-cell transplantation anti-gd2 antibody uttenreuther-fischer mm united therapeutics receives dinutuximab combination therapy chimeric antidisialoganglioside antibody antibody-dependent cytotoxicity anti-gd2 antibodies high-risk neuroblastoma patients article drugs aims multimodality therapy myeloablative therapy 18 consolidation therapy human neuroblastoma cells cell-mediated lysis privacy choices/manage cookies r24 monoclonal antibodies targeted immunotherapy complement-dependent cytotoxicity phase ia/ib trial chimeric antibody 14 high-risk neuroblastoma stem-cell rescue full article pdf dinutuximab beta treatment usage analysis hum antibodies hybridomas european economic area marketing authorization application mueller bm long term outcome conditions privacy policy antibody ch14 national cancer institute ozkaynak mf cancer chemother pharmacol article dhillon check access entire development process instant access
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headline:Dinutuximab: First Global Approval
description:United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I–III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy.
datePublished:2015-05-05T00:00:00Z
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Retinoic Acid
Neuroblastoma
Maximum Tolerate Dose
Lenalidomide
Population Pharmacokinetic Analysis
Pharmacotherapy
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Internal Medicine
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headline:Dinutuximab: First Global Approval
description:United Therapeutics Corporation and the National Cancer Institute are developing dinutuximab (Unituxin™; ch14.18), a monoclonal antibody targeting GD2, for the treatment of neuroblastoma. GD2 is a glycolipid found on the surface of tumour cells, which is overexpressed in neuroblastoma. Dinutuximab, an IgG1 human/mouse chimeric switch variant of murine monoclonal antibody 14G2a, binds to GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. The US FDA has recently approved the use of dinutuximab combination therapy for the treatment of high-risk neuroblastoma in paediatric patients. The marketing authorization application for dinutuximab is under regulatory review in the EU, and phase I–III development is underway in several other countries. This article summarizes the milestones in the development of dinutuximab leading to this first approval for use (in combination with granulocyte macrophage colony-stimulating factor, interleukin-2 and 13-cis retinoic acid) in the treatment of paediatric patients with high-risk neuroblastoma who achieve at least partial response to prior first-line multiagent, multimodality therapy.
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dateModified:2015-05-05T00:00:00Z
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Neuroblastoma
Maximum Tolerate Dose
Lenalidomide
Population Pharmacokinetic Analysis
Pharmacotherapy
Pharmacology/Toxicology
Internal Medicine
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