Corixa says FDA Panel to Review Bexxar
Tuesday November 5, 2:18 pm ET
SEATTLE (Reuters) - Pharmaceutical firms Corixa Corp. (NasdaqNM:CRXA - News) and GlaxoSmithKline Plc (London:GSK.L - News; NYSE:GSK - News) on Tuesday said their experimental non-Hodgkin's lymphoma drug Bexxar will be reviewed by a U.S. Food and Drug Administration advisory panel on Dec. 17.
Seattle-based Corixa, which has been trying to get Bexxar approved for more than three years, is seeking to market the drug for treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, a cancer that attacks the immune system and affects more than 50,000 Americans a year.
In March, the FDA rejected Corixa's application for Bexxar, saying it needed more proof of the drug's effectiveness. The rejection meant Corixa would have to conduct new trials of the drug, but the company appealed that decision and the FDA in June agreed to a new review of the drug.
"Our joint discussions with FDA over the past few months have helped clarify the significance of key findings from Bexxar clinical trials and we welcome the additional review and insight," Kevin Lokay, vice president of oncology at GlaxoSmithKline, said in a statement. Corixa and Britain's GlaxoSmithKline are codeveloping the drug in the United States.
Bexxar's development is well behind that of rival drug, Zevalin, which was launched early this year by IDEC Pharmaceuticals Corp. (NasdaqNM:IDPH - News).
Both drugs are antibodies designed to deliver cancer-killing radiation directly to tumors. |
