Dendreon files BLA for Provenge

Seattle-based Dendreon (DNDN [1]) has filed for FDA approval of the prostate cancer drug Provenge, taking another big step as it builds the framework for a national distribution system for the new therapy.

"With the BLA submission complete, we have taken an important step towards reaching our goal of bringing a new therapy to men with advanced prostate cancer," said Dendreon CEO Dr. Mitchell Gold, in a statement. "We look forward to working with the FDA to potentially make Provenge the first active cellular immunotherapy to be licensed in the United States."

Dendreon has been scouting for 250,000 square feet of additional space to accommodate its growing staff.  Dendreon has been making plans to manufacture Provenge in New Jersey initially and later add facilities in Atlanta and Los Angeles. Dendreon filed its application two years after the FDA asked for more data on the therapy.

- check out the report [2] from the Seattle Business Journal
- here's the report [3]from the Wall Street Journal

Related Articles:
Dendreon jumps on 'heavyweight' board appointments [4]
Dendreon blueprints $70M Provenge facility in Atlanta [5]
Dendreon CEO predicts an FDA approval for cancer vax [6]
Is Dendreon a likely takeover target? [7]