The Food and Drug Administration’s (FDA) go-ahead to Dendreon Corp.'s (DNDN) prostate cancer therapy has given hope to millions of patients who suffer from the dreaded disease.
Trying to get a green signal for Provenge since late 2006, Seattle-based Dendreon finally managed to get an approval from FDA Thursday. The approval marks success for the biotech firm which has invested 15 years and $1 billion to develop the treatment.
"It sets the stage, or at least facilitates the approval of other cancer vaccines. It is a watershed event in that regard," said Michael Becker, chief executive of MD Becker Partners, a management consulting firm for life science companies.
Provenge works by invigorating the immune system of the body to attack the disease. At present, surgery, radiation and hormone treatments are the usual approaches to thwart the disease.
"This is the first vaccine that builds your immune system to kill the cancer cells. That's what makes this exciting to me. If this can actually kill the cancer cells, it's really terrific," averred 85-year-old Jesse Seligman, who was diagnosed with prostate cancer 12 years ago.
The cost factor
The cheers are to be taken with a pinch of salt though. Provenge comes with a price tag of mammoth $93,000, which may well be out of the reach of the common man.
Provenge's rival is Taxotere, the chemotherapy drug that costs only about $18,000 per course.
Weather Medicare should fund cancer treatments is debatable, for some of these treatments extend life by, on average, only a few months.
However, Don McLeod, public affairs specialist for the Centers for Medicare and Medicaid Services said unequivocally, “When we make a coverage decision, cost is not a factor. It's pretty much automatic that if it's a cancer drug, we will approve it."
Limited availability initially
In the clinical trials conducted on 512 men whose body was no longer sensitive to hormone therapy and the prostate cancer had spread to other parts of the body, Provenge successfully increased median survival to 25.8 months, an increase by 4.1 months in the median survival of men who did not get the therapy.
The common side effects reported were flu-like symptoms. Cerebro-vascular complications, including strokes, were reported in 3.5 percent of the participants. This compares with a rate of 2.6 percent in the control population.
To begin with, Dendreon will roll out 2,000 courses of Provenge in the initial year. Furthermore, the therapy would be available only at the sites that participated in the clinical trials.