Dendreon this morning announced that Provenge, an immune therapy for certain forms of prostate cancer, provides statistically significant survival benefits for patients.
We have actually known this for almost two years, but the last time around the FDA decided to ask for a larger study to verify the earlier results.
The new study, a Phase III trial named IMPACT, enrolled 512 patients with metastatic androgen-independent prostate cancer, a late-stage cancer than usually kills men in a few months. The trial showed that on average men lived over 20% longer when they had received the Provenge treatment. The exact statistical results will be presented at a medical conference shortly.
This is going to have a major impact on the entire biotechnology industry. If the FDA now approves Provenge, as expected, it will be the first approved immunotherapy.
Immunotherapy research has been stifled by lack of funds because the FDA had never approved a therapy. When sales of Provenge begin, Dendreon should have the funds to both improve its therapy for prostate cancer and to create therapies for other forms of cancer.
It is important to note that Provenge in its current form is not a cure. Many prostate cancer victims get no response to it. This is probably because what we call prostate cancer is a range of disease. But some men who started Provenge therapy years ago are still alive, which is remarkable given what we know about the disease.
Congratulations to the people at Dendreon who kept going despite considerable pressure to pack it in from certain people on Wall Street and in the FDA.
I own a bit of Dendreon stock. It is still possible that the FDA will refuse to approve Dendreon despite these good results, or that it may not become commercially viable for some unknown reason.