On 2 October 2003, orphan designation (EU/3/03/162) was granted by the European Commission to Monoclonal Antibodies Therapeutics (MAT), France, for Yttrium (90Y) antiferritin polyclonal antibodies for the treatment of Hodgkin lymphoma.
- What is Hodgkin lymphoma?
Hodgkin lymphoma is a type of cancer that develops in the lymphatic system. The lymphatic system is part of the body’s immune system: the body's natural defence against infection and disease. It is a complex system made up of organs such as bone marrow (the spongy tissue inside the large bones in the body), the thymus and the spleen, and a network of lymph nodes throughout the body that are connected by lymphatic vessels. Because lymphatic tissue is found throughout the body, Hodgkin's lymphoma can begin in almost any part of the body and spread to almost any tissue or organ in the body. Normally, the proliferation of lymphatic cells takes place in a controlled manner but, in Hodgkin’s lymphoma, this process gets out of control and the cells continue to divide, developing into a tumour.
Hodgkin's lymphoma can occur in both adults and children; however, treatment for adults may be different than treatment for children. Hodgkin's lymphoma can usually be cured if found and treated early. However, despite the available treatments, Hodgkin lymphoma remains a serious and life-threatening condition in certain patients.
- What are the methods of treatment available?
Three different types of standard treatment are available and used: chemotherapy (using drugs to kill cancer cells), radiotherapy (using high-energy x-rays or other types of high-energy rays to kill cancer cells) and surgery (removing all possible cancer tissue in an operation). Bone marrow transplantation is also used. Several treatments had been authorised at the time of submission of the application for orphan drug designation.
Yttrium (90Y) antiferritin polyclonal antibodies could be of potential significant benefit for the treatment of Hodgkin lymphoma, because they may act in a different way than other types of treatment. This assumption will have to be confirmed at the time of marketing authorisation. This will be necessary to maintain the orphan status.
- What is the estimated number of patients affected by the condition*?
According to the information provided by the sponsor, Hodgkin lymphoma was considered to affect about 43,000 persons in the European Union.
*Disclaimer: The number of patients affected by the condition is estimated and assessed for the purpose of the designation, for a European Community population of 385,000,000 (Eurostat 2002) and may differ from the true number of patients affected by the condition. This estimate is based on available information and calculations presented by the sponsor at the time of the application.
- How is this medicinal product expected to act?
Yttrium (90Y) antiferritin polyclonal antibodies are a complex formed by specific antibodies linked to the radioactive form of a chemical called Yttrium. An antibody is a protein that targets and links specific shapes on the surface of foreign bodies, such as bacteria or cancer cells. Yttrium (90Y), is a chemical element, which can give off radiation. The antiferritin polyclonal antibodies are thought to recognise the tissues where Hodgkin lymphoma cells are. This might then trigger the body's immune system to attack the cancer cells. In addition, Yttrium (90Y) can give off radiation, which can damage and kill nearby cells, especially those that are dividing, such as cancer cells.
- What is the stage of development of this medicinal product?
At the time of submission of the application for orphan designation, no clinical trials in patients with Hodgkin lymphoma were initiated.
Yttrium (90Y) antiferritin polyclonal antibodies was not marketed anywhere worldwide for the Hodgkin lymphoma or designated as orphan medicinal product elsewhere for this condition, at the time of submission.
According to Regulation (EC) No 141/2000 of 16 December 1999, the Committee for Orphan Medicinal Products (COMP) adopted on 30 July 2003 a positive opinion recommending the grant of the above-mentioned designation.
- Opinions on orphan medicinal products designations are based on the following cumulative criteria:
(i) the seriousness of the condition, (ii) the existence or not of alternative methods of diagnosis, prevention or treatment and (iii) either the rarity of the condition (considered to affect not more than five in ten thousand persons in the Community) or the insufficient return of development investments.
Designated orphan medicinal products are still investigational products which were considered for designation on the basis of potential activity. An orphan designation is not a marketing authorisation. As a consequence, demonstration of the quality, safety and efficacy will be necessary before this product can be granted a marketing authorisation.
|Name||Language||First published||Last updated|
|EU/3/03/162: Public summary of positive opinion for orphan designation of Yttrium (90Y) antiferritin polyclonal antibodies for the treatment of Hodgkin lymphoma||(English only)||30/05/2007|
|Active substance||Yttrium (90Y) antiferritin polyclonal antibodies|
|Disease/condition||Treatment of Hodgkin lymphoma|
|Date of decision||02/10/2003|
|Orphan decision number||EU/3/03/162|
Review of designation
Sponsor’s contact details:
Monoclonal Antibodies Therapeutics
Genopole Campus 1
5 rue Henri Desbruères
91030 Evry Cedex
Telephone: + 33 160 917 880
Telefax: + 33 160 917 899
Patients associations’ contact points:
The Lymphoma Association
PO Box 386 Aylesbury Bucks HP20 2GA
Telephone: (44-1296) 61 94 00
Associazione Italiana contro le Leucemie - linfomi e mieloma ONLUS
Via Ravenna, 34
I- 00161 Roma
Telephone: +39 06 4403763
Telefax: +39 06 4404226