Avustralya"nın verdiği karar, Talidomid"in multipl myelom tedavisi için aldığı ilk onay olacak.
Australia Recommends Approval of Thalidomide For Treatment of Relapsed and Refractory Multiple Myeloma, and Complications of Leprosy
WARREN, NJ -- August 19, 2003 -- Australian Drug Evaluation Committee has recommended for approval Pharmion"s thalidomide for the treatment of both patients with relapsed and refractory multiple myeloma (MM) and for the treatment of cutaneous manifestations of erythema nodosum leprosum (ENL), a severe and debilitating condition associated with leprosy.
The milestone decision in Australia will represent the first approval worldwide for thalidomide as a therapy for relapsed and refractory multiple myeloma. The U.S. Food and Drug Administration approved thalidomide for the treatment of cutaneous manifestations of erythema nodosum leprosum (ENL) in July 1998.
The recommendation for approval of thalidomide in Australia reflects a real recognition of the critical need for new treatment options for multiple myeloma (MM). Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2002, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2002 was 57,370 worldwide.