It is given in patients who have completed induction therapy and consolidation therapy (autologous bone marrow transplant and external beam radiation therapy), as part of standard-of-care therapy for newly-diagnosed high-risk neuroblastoma. It is given by intravenous infusion, over ten to twenty hours, four days in a row. It is also used second-line for relapsed/refractory neuroblastoma in combination with chemotherapy and GM-CSF. Dinutuximab beta is also used as a second line treatment for children with high-risk neuroblastoma; it was tested and is used with a longer and slower dosing regime, and is given on its own, although it may be combined with IL-2 if a stronger immune response is needed.Morphine is administered prior to, during, and for two hours after infusion of dinutuximab and dinutuximab beta to manage the severe pain that this drug causes. An antihistamine and an anti-inflammatory are also given before, during, and after to manage the infusion reaction.Women who are pregnant or who might become pregnant should not take dinutuximab or dinutuximab beta, because it is very likely to cause harm to a fetus. Adverse effects
The US label for dinutuximab carries black box warnings for life-threatening infusion reactions and neurotoxicity, as it causes severe neuropathic pain, and can cause severe sensory neuropathy and severe peripheral motor neuropathy.
A lab at the Childrens Cancer Research Institute in Vienna, in collaboration with a network of European oncologists, had developed an anti-GD2 mAb that it made in CHO cells, and by 2011, it was in Phase III clinical trials, and the institute licensed its rights to Apeiron, a local biotech company.The FDA approved United Therapeutics application in March 2015, as did the European Medicines Agency.In 2017, United Therapeutics withdrew the European marketing authorization, and said that it was having trouble making enough of the drug to sell in Europe.In October 2016, Apeiron licensed the rights to Ch14.18 to the UK biotech company, EUSA, and in May 2017, Apeiron and EUSA obtained EMA approval to market Ch14.18, by then called dinutuximab beta. References
External links
"Dinutuximab". Drug Information Portal. U.S. National Library of Medicine. "Dinutuximab beta". Drug Information Portal. U.S. National Library of Medicine.