Dinutuximab beta [DIN1]
Dinutuximab beta as part of 1st line therapy for high risk neuroblastoma in patients aged 12 months and above and who have both responded to induction chemotherapy and been treated with myeloablative therapy and stem cell transplantation where the following criteria are met:
- An application is being made by and the first cycle of systemic anti-cancer therapy with dinutuximab beta will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for hypersensitivity reactions, capillary leak syndrome, neuropathic pain, peripheral neuropathy and ocular toxicity
- The patient is currently aged 12 months or older and has histologically documented neuroblastoma according to the International Neuroblastoma Staging System (INSS)
- The patient has high risk disease defined as either INSS stage 2, 3 , 4 and 4s with MYCN amplification or INSS stage 4 without MYCN amplification and aged >12 months at diagnosis
- The patient achieved at least a partial response to induction chemotherapy (defined as whatever the sequence of therapies which subsequently led to myeloablative therapy).
- The patient was treated with myeloablative therapy and stem cell transplantation
- The patient remains free of disease progression following induction chemotherapy and stem cell transplantation
- The patient has not received prior treatment with an anti-GD2 antibody antibody unless they were treated with dinutuximab beta as part of induction therapy (as defined above) in the SIOPEN HR-NBL-2 or SIOPEN Pilot studies and all other treatment criteria listed on this form are fulfilled.
- Dinutuximab beta is not being given in combination with interleukin-2
- A formal medical review as to whether treatment with dinutuximab beta should continue or not and at what dose will be scheduled to occur at least by the end of the first cycle of treatment
- The patient will be treated until disease progression or excessive toxicity or completion of 5 cycles of therapy or patient/parent/guardian (as appropriate) choice to discontinue treatment, whichever is the sooner
- Treatment breaks of up to 6 weeks beyond the expected cycle length are allowed
- Dinutuximab beta will otherwise be used as set out in its Summary of Product Characteristics (SPC)
NHS funded From: 20 November 2018
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.