European regulators have green-lighted United Therapeutics’ Unituxin for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years.
The European Medicines Agency has ruled that the drug, a monoclonal chimeric antibody, can be used in those who have had induction chemotherapy and at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation.
According to United, neuroblastoma is the most common extra-cranial solid cancer in childhood and the most common cancer in infancy, with an annual incidence in the European Union of around 1,500 patients, half of whom have high-risk forms of the disease.
Approval of Unituxin (dinutuximab) came on the back of clinical data showing both improved event-free and overall survival in a multicenter, open-label, randomised trial sponsored by the US National Cancer Institute and conducted by the Children's Oncology Group.
But it also comes with a hefty list of side effects, including nerve cell irritation causing severe pain that requires treatment with intravenous narcotics, as well as life-threatening infusion reactions, and, as such, is subject to additional monitoring for “quick identification of additional safety information”.
Earlier this year, the drug also became the first to be approved by the US Food and Drug Administration for paediatric patients with high-risk neuroblastoma.