Dendreon (DNDN) has added another round of positive data to its impressive case for Provenge, a closely-watched prostate cancer vaccine that has been tagged with a May 1 PDUFA date. Researchers report that updated three-year survival results demonstrated a 40 percent increase in survival compared to placebo. And that backs up the 38 percent improvement in survival for treatment-resistant patients at 34 months.
Patients who were treated with Provenge, which is designed to spur the human immune system to mount an attack on cancer cells, lived an average of 4.1 months longer than patients in the control arm of the study.
Seattle-based Dendreon intends to make biotech history with the first immunotherapy approved for cancer. And it is acting with supreme confidence, raising hundreds of millions of dollars and building facilities across the U.S. that will be used to customize the therapy for each patient. Investors showed their approval for the new data point by nudging the company's shares up by three percent in after-market trading.
Dendreon was asked by the FDA in 2007 to go back to the clinic and mount a new late-stage study of Provenge, despite an advisory committee vote in its favor. Regulators wanted to see more proof of efficacy, and Dendreon has delivered. Analysts peg Provenge as a likely blockbuster and an approval soon would prove transformational for Dendreon.