The FDA has approved Dendreon's Provenge, a breakthrough cancer vaccine that promises to extend the lives of prostate cancer victims by several months.
Widely seen as a likely blockbuster with a cost of around $75,000 per patient, the approval comes after the Seattle-based Dendreon (NASDAQ: DNDN) braved a major setback at the FDA in 2007 and forged ahead with a confirmatory Phase III study of the therapy. Betting that the agency would go ahead with an approval, Dendreon has invested hundreds of millions of dollars in the infrastructure that will be needed to supply the cancer vaccine, which is made with a patient's own white cells.
The approval marks a transformative change for Dendreon, which is likely to vault into the top ranks of the world's biotech companies as revenue from Provenge funds additional discovery work. The decision by the FDA is one of the most closely-watched of the year. In recent days most of the major media outlets in the country have been showering the company with the kind of attention most biotechs only dream about.
Dendreon received its first positive Phase III data on Provenge back in 2003. Its stock, already up 50 percent, immediately spiked 15 percent.
- see the FDA's release on the approval