Unituxin (dinutuximab)
Product Summary
• Product description - name, strength and form: Unituxin 3.5 mg/mL concentrate for solution for infusion.
• Route of administration: intravenous infusion
• Dinutuximab is indicated to treat high-risk neuroblastoma in people aged 12months-17 years, who have received induction chemotherapy previously and achieved a minimum of a partial response, followed by myeloblative therapy and autologous stem cell transplantation.
• Mechanism of action drug substance: dinutuximab is a monoclonal chimeric antibody. Dinutuximab reacts specifically with the ganglioside GD2. On the surface of neuroblastoma cells GD2 is highly expressed whereas GD2 is sparsely expressed on the surface of normal human neurons, skin melanocytes and peripheral pain fibres.
• Dosage regime: Unituxin is intended to be administered by iv infusion for four consecutive days during five monthly courses at a …show more content…
The withdrawal was initiated by the marketing authorisation holder (MAH), United Therapeutics Europe Ltd, which had requested the European Commission to withdraw the marketing authorisation due to short- and intermediate- term inability to supply Unituxin in sufficient quantities for meeting current global demands. The MAH has confirmed that it has no future plans to commercialise Unituxin in the EU until the supply issues have been resolved. Unituxin was granted marketing authorisation in the EU on 14 August 2015 for the treatment of high risk neuroblastoma and the marketing authorisation was initially valid for a 5-year period. The MAH has confirmed that any neuroblastoma patients who are currently receiving Unituxin treatment will have the possibility to receive the full treatment until completion of the 5 courses. No new patients with high risk neuroblastoma will be started on Unituxin therapy due to the lack of drug
Product Summary
• Product description - name, strength and form: Unituxin 3.5 mg/mL concentrate for solution for infusion.
• Route of administration: intravenous infusion
• Dinutuximab is indicated to treat high-risk neuroblastoma in people aged 12months-17 years, who have received induction chemotherapy previously and achieved a minimum of a partial response, followed by myeloblative therapy and autologous stem cell transplantation.
• Mechanism of action drug substance: dinutuximab is a monoclonal chimeric antibody. Dinutuximab reacts specifically with the ganglioside GD2. On the surface of neuroblastoma cells GD2 is highly expressed whereas GD2 is sparsely expressed on the surface of normal human neurons, skin melanocytes and peripheral pain fibres.
• Dosage regime: Unituxin is intended to be administered by iv infusion for four consecutive days during five monthly courses at a …show more content…
The withdrawal was initiated by the marketing authorisation holder (MAH), United Therapeutics Europe Ltd, which had requested the European Commission to withdraw the marketing authorisation due to short- and intermediate- term inability to supply Unituxin in sufficient quantities for meeting current global demands. The MAH has confirmed that it has no future plans to commercialise Unituxin in the EU until the supply issues have been resolved. Unituxin was granted marketing authorisation in the EU on 14 August 2015 for the treatment of high risk neuroblastoma and the marketing authorisation was initially valid for a 5-year period. The MAH has confirmed that any neuroblastoma patients who are currently receiving Unituxin treatment will have the possibility to receive the full treatment until completion of the 5 courses. No new patients with high risk neuroblastoma will be started on Unituxin therapy due to the lack of drug