Date: 2017-05-09
Type of information: Granting of a Market Authorisation in the EU
Product name: Isqette/Qarziba® (APN311 - dinutuximab beta)
Compound: dinutuximab beta
Therapeutic area: Rare diseases - Cancer - Oncology
Action mechanism:
- monoclonal antibody. Isqette® is a monoclonal antibody that has been designed to recognise and attach to GD2 antigen. This antigen is present in high amounts on the surface of neuroblastoma cells, but not normal cells. When the medicine attaches to the neuroblastoma cells, it marks them out as a target for the body’s immune system, which is then expected to attack the cancer cells and thereby reverse or slow down the progression of the disease.
- Dinutuximab beta has been generated and profiled by European academic institutions originating at the Clinical Cancer Research Institute in Vienna (St. Anna Children's Hospital), initiated by Prof. Ladenstein. The development was extended to multiple clinical trials across Europe and abroad, performed by the SIOPEN neuroblastoma study group and the German group at the University Children's Hospital Greifswald led by Prof. Lode.
- Apeiron Biologics has granted EUSA Pharma, exclusive global commercialization rights to Isqette® (APN311, dinutuximab beta) in October 2016.
Company: Apeiron Biologics (Austria)/EUSA Pharma (UK)
Disease: neuroblastoma
Latest news:
- • On May 9, 2017, EUSA Pharma announced that the European Commission (EC) has approved ch14.18/CHO, dinutuximab beta, for the treatment of high-risk neuroblastoma in patients aged 12 months and above. This
announcement makes dinutixumab beta the only approved immunotherapy in Europe for high risk neuroblastoma.
Neuroblastoma, is the second most common solid tumour in childhood, following brain tumours,and predominantly affects children under five years old. Every year in Europe, around 1,200 children are diagnosed with neuroblastoma, a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissues. The next challenge will be for EUSA Pharma to engage with relevant access bodies throughout Europe, including NICE in the UK, to ensure timely review through the new drugs processes and secure access to this medicine for patients.
- • On March 23, 2017, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation under exceptional circumstances for dinutuximab beta Apeiron (dinutuximab beta) for the treatment of high-risk neuroblastoma. This medicine has an orphan designation .
- More than 1,000 patients have been treated and the results served as basis for Marketing Authorization Application (MAA) in the EU in 2015.
- • On November 8, 2012, the European Commission has granted orphan drug designation to chimeric monoclonal antibody against GD2 for the treatment of neuroblastoma.
- • On October 4, 2012, the Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending chimeric monoclonal antibody against GD2 for designation as an orphan medicinal product for treatment of neuroblastoma.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2017-05-09
Favourable opinion UE: 2017-03-23
Favourable opinion USA:
Orphan status USA: 2010-12-20
Orphan status UE: 2012-11-08
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
