Entries in Dendreon (1)


FDA Approves Increased Availability of Prostate-Cancer Drug Provenge

Comstock/Thinkstock(NEW YORK) -- The U.S. Food and Drug Administration has approved an increase in production of prostate cancer drug Provenge to four times its current capacity.

The drug was initially approved by the FDA last April, but demand for the drug exceeded the company's original production constraints.

Provenge combats prostate cancer by inducing an immune response to the disease with the use of a patient's own cells.  After the cells are shipped to Dendreon Corporation, the drug's manufacturer, they are processed and returned to the patient's medical doctor and administered through an IV.  This process must take place three times over a four week period.

The FDA's approval to increase production now allows Dendreon to grow its number of workstations from 12 to 48.

Chief Executive Mitchell Gold told The Wall Street Journal Thursday, "The availability of the increased capacity is going to allow more treatment centers across the country to access Provenge."

Originally, Provenge was offered at 50 clinical sites at last year's launch.  But the company expects the drug to be available at around 500 sites by the end of this year.

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