Dendreon Corp. (NASDAQ: DNDN) has been facing problems getting its Provenge sales for advanced metastatic prostate cancer through to the market. Even a direct to consumer advertising campaign has so far failed to help. Now we have word that the U.S. Food & Drug Administration (FDA) has approved Xofigo, Bayer’s drug to treat certain types of advanced prostate cancer.
Xofigo is meant to treat metastatic prostate cancer, but only cancers that have spread into the bones rather than into other organs. The treatment also is approved only for those who have received other therapies aimed at lowering testosterone. The drug is designed to help deliver radiation directly to bone tumors, limiting damage to other tissue and organs. The drug was originally called Alpharadin or radium-223 chloride.
What is interesting is that this approval appears to be about three months ahead of the drug approval deadline in August. The FDA had granted a priority review status to Bayer and partner Algeta in Norway.
Today’s approval should only be a surprise as far as the timing is concerned. Bayer and Algeta ended the late-stage study as its independent monitoring committee determined that the drug already met its primary endpoint and increased the overall survival by 44%, raising the median average to 14 months versus 11.2 months in the placebo group. The drug also lowered pain in the bones for patients.
Dendreon investors already felt the bulk of their pain. Now the stock is still up by $0.01 at $4.18 on 3.1 million shares. Its 52-week trading range is $3.69 to $9.03. Again, the big surprise here is the timing of the FDA approval rather than the FDA drug approval itself.