EU/3/07/523

About

This medicine is now known as lutetium (177Lu) oxodotreotide.

On 31 January 2008, orphan designation (EU/3/07/523) was granted by the European Commission to BioSynthema Global Operations B.V, the Netherlands, for lutetium (177Lu)-N-[(4,7,10-tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide for the treatment of gastro-entero-pancreatic neuroendocrine tumours.

The sponsorship was transferred to Advanced Accelerator Applications, France, in September 2011.

Lutetium (177Lu)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide has been authorised in the EU as Lutathera since 26 September 2017.

Key facts

Active substance
Lutetium (177Lu)-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide (lutetium (177Lu) oxodotreotide)
Disease / condition
Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of decision
31/01/2008
Outcome
Positive
Orphan decision number
EU/3/07/523

Review of designation

On 25 July 2017, the Committee for Orphan Medicinal Products (COMP) completed a review of the designation EU/3/07/523 for Lutathera (lutetium (177Lu) oxodotreotide) as an orphan medicinal product for the treatment of gastro-entero-pancreatic neuroendocrine tumours. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with gastro-entero-pancreatic neuroendocrine tumours. The COMP recommended that the orphan designation of the medicine be maintained1.


1The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

Advanced Accelerator Applications
20 rue Diesel
01630 Saint-Genis-Pouilly
France
Tel. +33 4 50 99 30 76
E-mail: Regulatory_Affairs@adacap.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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