YONDELIS(R) Granted Orphan Drug Designation by the U.S. FDA For The Treatment of Ovarian Cancer.
PR Newswire Europe, April, 2005
MADRID, Spain, April 7 /PRNewswire/ -- PharmaMar announced today that its marine-derived anti-cancer drug, YONDELIS(R) (trabectedin), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ovarian cancer. The U.S. application sponsor, is Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), co-developing the compound with PharmaMar. The European Commission granted orphan drug status to YONDELIS for this indication in Europe in 2003.
Ovarian cancer
In the western world, ovarian cancer represents 4% of all cancers among women and ranks fifth as a cause of female deaths from cancer (American Cancer Society (ACS), Cancer Reference Information, 2005). The death rate for this...
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