Thalidomide Pharmion has been approved in Turkey for the treatment of multiple myeloma after the failure of standard therapies as well as for the treatment of a severe and debilitating complication of leprosy, said Pharmion Corporation.
The Turkish approval requires a strict monitoring system to be used to control the use and distribution of thalidomide, which is met by the Pharmion Risk Management Program (PRMP).
Turkey is the third country outside the US to approve thalidomide, following the registrations in Australia and New Zealand for the same indications in the fourth quarter of 2003.
"The decision by the Turkish authorities to approve Thalidomide Pharmion, our third approval in a short period of time, demonstrates their recognition of the benefits thalidomide can provide for patients with multiple myeloma," said Patrick J. Mahaffy, Pharmion's president and chief executive officer.
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Multiple myeloma is the second most common cancer of the blood, representing approximately one per cent of all cancers and two per cent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. There are approximately 13,000 multiple myeloma patients in Turkey, with an estimated additional 3,000 new patients per year. The cause of the disease is unknown.
Pharmion is developing and commercializing products for the treatment of hematology and oncology patients.