|AVAILABLE IN ORIGINAL FORM: PDF EMEA ORPHAN DRUG DESIGNATION|
European Medicines Agency
Pre-authorisation Evaluation of Medicines for Human Use
Document Date: London, 30 November 2007
COMMITTEE FOR ORPHAN MEDICINAL PRODUCTS PUBLIC SUMMARY OF
POSITIVE OPINION FOR ORPHAN DESIGNATION OF
for the treatment of pancreatic cancer
On 8 June 2007, orphan designation (EU/3/07/451) was granted by the European Commission to
What is pancreatic cancer?
Cancer that begins in the pancreas is called pancreatic cancer. The pancreas is a small organ that lies behind the stomach and in front of the spine. The pancreas has two main functions in the body: first, it produces a juice that helps to digest (break down) and absorb food; second, it produces hormones (substances that circulate in the blood), such as insulin, that help to control blood sugar levels. About
What are the methods of treatment available?
The choice of the treatment of pancreatic cancer depends on several factors, including the stage of the disease. Treatments may include surgery, radiation therapy (using high-dose x-rays or other high- energy rays to kill cancer cells), and chemotherapy (using drugs to kill cancer cells). There are anti- cancer drugs that have been authorised for treatment of pancreatic cancer. Cisplatin (liposomal) might be of potential significant benefit for the treatment of pancreatic cancer. It might offer a treatment to patients for whom other anti-cancer agents are not effective. 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 pancreatic cancer** ?
According to the information provided by the sponsor, pancreatic cancer was considered to affect approximately 55,000 persons in the European Union.
How is this medicinal product expected to act?
Cisplatin (liposomal) is a new formulation of cisplatin, which has been an anti-cancer drug for a long time. The inclusion of cisplatin in liposomes (special particles coated with molecules of fat) is expected to increase the concentration of the drug in the cancer cells, compared to normal cells, and decrease the adverse effects of the drug. Cisplatin works by damaging and eventually killing cancer cells, through the formation of special compounds, called “reactive oxygen species”, which are toxic for the cells.
* Disclaimer: For the purpose of the designation, the number of patients affected by the condition is estimated and assessed based on data from the European Union (EU 25), Norway, Iceland and Lichtenstein. This represents a population of
459,700,000 (Eurostat 2004). This estimate is based on available information and calculations presented by the sponsor at the
time of the application.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 40
©EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
What is the stage of development of this medicinal product?
At the time of submission of the application for orphan designation, clinical trials in patients with pancreatic cancer were ongoing.
For more information: Sponsor’s contact details: Regulon AE
Patients associations’ contact points:
Ligue Nationale Contre le Cancer
13 Av. de la Grande Armee
3 Bath Place Rivington Street London
The Association of European Cancer Leagues (ECL)
c/o Belgian Federation against Cancer
Translations of the active ingredient and indication in all EU languages and Norwegian and Icelandic
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