FDAnews
www.fdanews.com/articles/71555-fda-grants-orphan-drug-status-to-bioalliance-s-cancer-candidate

FDA Grants Orphan-Drug Status to BioAlliance's Cancer Candidate

April 26, 2005

The FDA has granted orphan-drug status to BioAlliance Pharma's Transdrug (doxorubicin) for the treatment of hepatocellular carcinoma, a potentially fatal form of liver cancer.

The drug employs a proprietary polymer formulated as a nanoparticle to deliver doxorubicin, a proven active cancer drug, to the site of the liver tumor via a catheter placed in the hepatic artery. Transdrug is currently completing Phase I/II clinical testing in the European Union.