DINUTUXIMAB BETA EUSA (dinutuximab beta), monoclonal antibody
RARE DISEASE - New medicinal product
Opinions on drugs - Posted on Mar 29 2018
Reason for request
Substantial clinical benefit and minor clinical added value in the management of the maintenance phase of high-risk neuroblastoma
but no clinical added value demonstrated in the management of relapsed or refractory neuroblastoma
- DINUTUXIMAB BETA EUSAhas Marketing Authorisation in the treatmentof patients > 12 months of age with high-risk neuroblastoma, who have previously received an induction chemotherapy and had at least a partial response, followed by a myeloablative therapy and a haematopoietic stem cell transplant, as well as in patients with relapsed or refractory neuroblastoma, with or without residual disease.
- The only comparative study available in the maintenance phase of high-risk neuroblastoma did not demonstrate a benefit from adding an interleukin-2 (IL-2) to the combination of dinutuximab beta and isotretinoin.
- The efficacy data in the treatment of relapsed or refractory neuroblastoma, with or without residual disease, are of a low level of evidence.
- The main characteristics of the safety profile are pain, reduced by the use of a continuous perfusion, and capillary leak syndrome.
- There is insufficient evidence on possible long-term consequences, especially neurological consequences, of treatment with dinutuximab beta for the target population of young children.
Improvement in actual benefit
Évaluation des médicaments