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Biopharmaceuticals Oncology Regulatory

 News Release - March 27, 2017

Dinutuximab beta receives positive recommendation for the treatment of high-risk neuroblastoma in Europe

HEMEL HEMPSTEAD, England, March 27, 2017 -- (Healthcare Sales & Marketing Network) --EUSA Pharma today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in favour of marketing authorization for the antibody ch14.18/CHO, Dinutuximab beta, for the treatment of children aged 12 months and above , who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2). Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures[1].

Neuroblastoma is the second most common solid tumour in childhood, following brain tumours[2], and predominantly affects children under 5 years old[3]This welcome move towards European approval means that children affected by this aggressive form of cancer are one step closer to improved access to the new monoclonal antibody treatment, Dinutuximab beta.

Every year in Europe alone, around 1,200 children are diagnosed with neuroblastoma[4], a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissues[2]. Certain types of neuroblastoma spread quickly, which means that almost half of children are already at an advanced stage, or 'high-risk', when they're diagnosed, with a poor prognosis. Dinutuximab beta offers new hope to these children as a first line therapy or for those have not responded to other forms of treatment or relapsed despite intensive courses of radiation and chemotherapy.

"Today's news is an important milestone for the neuroblastoma research and patient communities that have witnessed the positive outcomes for children treated by Dinutuximab beta in the clinical trials", commented Dr Juliet Gray, Associate Professor and Consultant in Paediatric Oncology at University of Southampton. "As a clinician working with limited treatment options for those with high-risk neuroblastoma, I welcome this positive step towards a new, targeted immunotherapy that I can be confident offers improved results for this group in combination with existing therapies."

Steve Richards, CEO of the neuroblastoma charity Solving Kids' Cancer Europe, added: "Despite the most intensive of treatment regimens, high-risk neuroblastoma remains a death sentence for more than half of the children diagnosed. Anti-GD2 monoclonal antibody therapy has become an important weapon in the fight against this devastating disease, and is widely considered standard of care by clinicians and parents alike. The positive opinion granted today means that in future, children will be afforded the very best chance of survival, which is the least the innocent victims of this childhood cancer deserve."

Dinutuximab beta is currently used in Europe under a managed access programme as part of treatment regimens for high-risk neuroblastoma. This was first established by Apeiron Biologics, the company that developed Dinutuximab beta with the SIOPEN academic neuroblastoma group[5] and has subsequently been continued by EUSA, which holds exclusive global commercial rights to Dinutuximab beta.

Following the CHMP positive opinion, the European Commission will now issue a formal decision by the end of May, and if approved Dinutuximab beta will be indicated for use in the 28 countries of the European Union in children with high-risk neuroblastoma who have achieved at least a partial response to induction chemotherapy followed by myeloablative therapy and stem cell transplantation as well as children with a history of relapsed or refractory disease.

About Dinutuximab beta

Dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen, GD2, on neuroblastoma cells. It has been investigated in clinical trials for high-risk neuroblastoma, with more than 1000 patients having received treatment to date. Dinutuximab beta has orphan drug designation in the US and EU, and EUSA plans to file the product for approval in the United States in 2017.

Dinutuximab beta is currently available under a managed access programme. More information about how healthcare professionals can access the programme can be found on the EUSA Pharma website.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations across Europe and the USA, and a wider distribution network in approximately 40 further countries. The management team comprises highly experienced pharmaceutical professionals with a broad experience and proven track record of successfully identifying, developing and commercializing innovative medicines that advance patient care and improve their wellbeing. For more information visit: http://www.eusapharma.com.

References
  1. Committee for Medicinal Products for Human Use (CHMP). Summary of opinion -Dinutuximab beta. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/03/news_detail_002712.jsp&mid=WC0b01ac058004d5c1Last accessed March 2017.
  2. SIOPEN. Neuroblastoma. Available at: http://www.siopen.org/neuroblastoma. Last accessed March 2017.
  3. Macmillan Cancer Support. Neuroblastoma in Children. Available at: http://www.macmillan.org.uk/cancerinformation/cancertypes/childrenscancers/typesofchildrenscancers/neuroblastoma.aspx. Last accessed March 2017.
  4. L.E.K analysis of Tulla et al; Laranaga et al; Italian Tumour Registry; Cancer Research UK; NAACCR; EUROSTAT; US Census Bureau.
  5. http://www.apeiron-biologics.com


Source: EUSA Pharma

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