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http://www.washingtonpost.com/wp-dyn/articles/A55848-2003Jul1.html

FDA Approves New Drug for Cancer Patients

Reuters
Tuesday, July 1, 2003; Page A06

NEW YORK -- The Food and Drug Administration has approved a new drug for non-Hodgkin's lymphoma, a cancer that often starts in the lymph nodes and then spreads, manufacturers GlaxoSmithKline Plc and Corixa Corp. said yesterday.

The approval is the latest of a handful of new cancer drugs to be cleared by the FDA this year. The treatment, intended for patients with severe lymphoma who have failed other therapies, was delayed for 31/2 years as the FDA demanded more data from the companies.

An FDA panel in December backed the efficacy of the medicine, called Bexxar, but did not vote on whether it should be approved.

The drug could generate sales of $185 million in 2007, said SG Cowen Securities analyst Philip Nadeau.

Bexxar is a combination of radioactive iodine and an antibody -- a protein released by the immune system -- that looks for certain chemicals on cancer cells, then delivers lethal radiation to the tumors. The treatment involves four components and is administered in two steps over seven to 14 days.

Corixa and GlaxoSmithKline, the world's second-largest drug maker, will jointly market Bexxar in the United States.

Bexxar joins Rituxan and Zevalin in a crop of new biotech drugs for non-Hodgkin's lymphoma. Rituxan is marketed by Genentech Inc. and IDEC Pharmaceuticals Inc., and Zevalin was developed by IDEC alone.

© 2003 The Washington Post Company

 

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