Neuroblastoma (high-risk) - dinutuximab (maintenance, after therapy) [ID799]
Discontinued
Reference number: GID-TAG507
The company, United Therapeutics Corporation (UTC) has informed NICE that the commercial and investigational demands for dinutuximab in the United States (US) have significantly exceeded expectations and are outstripping the company’s ability to supply enough medicine to meet all global needs. Therefore, UTC has been taking steps to address this issue. It noted that manufacturing this type of medicine (a monoclonal antibody; also referred to as a biologic) is complicated and must be done in specialized facilities; thus, the amount of medicine that can be produced is currently limited. UTC is in the process of expanding its production capacity and it will take approximately 3 years to complete the new manufacturing facility and gain regulatory approval before the company can begin producing significantly more dinutuximab; the company expects this expansion will quadruple the supply of dinutuximab.
UTC has stated that, in the meantime, its priorities are maintaining supply of dinutuximab for the treatment of paediatric patients with high-risk neuroblastoma in the US, where it is already commercially available, and supplying ongoing clinical development programmes. Therefore, dinutuximab will not be available outside of the US until such time UTC is confident it can meet the needs in additional countries.
If you have questions or concerns regarding the availability of dinutuximab, please contact UTC’s Global Medical Information department at druginformation@unither.com
Given this information, NICE has taken the decision to suspend the ongoing appraisal of dinutuximab until there is certainty about the availability of dinutuximab in England.