Major turnaround for Dendreon as US FDA approves Provenge for advanced prostate cancer
In a reversal of previous decisions, the US Food and Drug Administration has approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease, developed by Dendreon. The company's shares plummeted three years ago, when the FDA delayed clearing the drug, calling for additional safety and efficacy data.
The approval is a major milestone for Dendreon, the tiny biotechnology company that developed the treatment based on basic research that occurred at Stanford University, notes a comment from Forbes magazine. Dendreon shares, which have risen more than 200% in the past year, rose a further 6% to $45 on news of the approval. Then they were halted. When trading restarted, the shares rose 31%, to $52.
Blockbuster status predicted
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