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Home Industry News Eusa Pharma receives EU approval for new high-risk neuroblastoma therapy

Eusa Pharma receives EU approval for new high-risk neuroblastoma therapy

11th May 2017

Eusa Pharma has announced that dinutuximab beta, its new treatment for high-risk neuroblastoma, has been approved in Europe.

The European Commission has ratified the drug for use in the treatment of high-risk neuroblastoma in patients aged 12 months and above, making it the only approved immunotherapy in Europe for this indication.

A monoclonal chimeric antibody developed to target a specific antigen on neuroblastoma cells, dinutuximab beta has demonstrated its safety and efficacy in clinical trials, with more than 1,000 patients having received treatment to date.

Neuroblastoma is the second most common solid tumour in childhood, predominantly affecting children under five years old. It can spread quickly, meaning almost half of children are initially diagnosed at an advanced stage of their disease, with a poor prognosis.

Lee Morley, chief executive officer of Eusa Pharma, said: "We are delighted that the European Commission has recognised the urgent need to accelerate approval of dinutuximab beta in order to provide an effective and targeted treatment for this debilitating disease."

The company is also hoping to file for US regulatory approval of the drug this year.

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